Académique Documents
Professionnel Documents
Culture Documents
Service Manual
For use with software version 7.xx
Manufacturer:
Gambro Lundia AB
Box 10101, Magistratsvägen 16, SE-220 10 Lund, Sweden
Tel: +46-46-16 90 00, Fax: +46-46-16 96 96
www.gambro.com
Questions or comments about this publication can be directed to your local representative or to the manufacturer.
Order number:
G5005209
Copyright:
© 2005–2012 Gambro Lundia AB
Gambro, Prismaflex, Adsorba, Prismaflo, Prismacomfort, Prismatherm, MARSFLUX, diaFLUX, diaMARS, X-MARS,
septeX, oXiris, Hospal and MARS are trademarks belonging to the Gambro Group.
G5005209
Program version 7.xx
This page is intentionally left blank
G5005209
Program version 7.xx
Prismaflex® Service Manual
1. Before you get started
2. Installation Guide
3. Technical Description
4. Function Check
5. Alarms and Troubleshooting
6. Maintenance
7. Schematics
8. Specifications
9. Equations
G5005209
Program version 7.xx
Contents
2. Installation Guide
3. Technical Description
G5005209
Program version 7.xx
Interior — Front 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:18
Interior — Front 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:20
Interior — Front 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:22
Interior — Front 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:24
Electrical Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:28
Internal Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:28
Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:31
Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:33
Carrier Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:34
Control CPU . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:35
Protective CPU board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:36
ARPS board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:38
PIB board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:40
Alarm light module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:41
LVDS interface board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:41
External RS232 board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:41
External Ethernet board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:41
External Remote Alarm Connector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:42
Fluid pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:42
Blood pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:42
Syringe pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:43
Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:43
Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:43
ABD assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:44
Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3:45
4. Function Check
G5005209
Program version 7.xx
Prismaflex® Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:5
Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:5
Overridden Malfunction Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:6
Caution Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:7
Prismaflex® Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:7
Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:7
Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:8
Prismaflex® Control Unit Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:8
Operator Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:8
Overridden Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:8
Alarm Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:9
Alarm Priority List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:9
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:14
About the Troubleshooting Chapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:14
Warning Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:15
Caution Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:39
Advisory Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:48
Malfunction Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:66
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5:97
Power Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5:101
6. Maintenance
G5005209
Program version 7.xx
Power Supply Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:20
Exchange of Lead Batteries for Battery Backup . . . . . . . . . . . . . . . . . . . . . . 6:20
Service Mode - Checkout using Service Diagnose Mode . . . . . . . . . . . . . . . . . . 6:21
Service Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:22
Service - Diagnose Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:24
Diagnose Screen – Pumps Diagnose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:26
Diagnose Screen – Scale Diagnose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:28
Diagnose Screen – Pressure Pod Reposition . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:30
Diagnose Screen – Alarms Tone and Light . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:32
Diagnose Screen – Air Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:34
Diagnose Screen – Syringe Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:36
Diagnose Screen – Clamp and Pinch Valves . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:41
Diagnose Screen – BLD (Blood Leak Detector) . . . . . . . . . . . . . . . . . . . . . . . . . 6:43
Diagnose Screen – Internal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:44
Diagnose Screen – Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:45
Diagnose Screen – PM timer and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:53
Diagnose Screen – Clean Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:55
Diagnose Screen – SW Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:56
Diagnose Screen – 2D Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:57
Service Calibration Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:58
Calibration Screen – Language Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . 6:60
Calibration Screen – Scales Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:61
Calibration Screen – Pressure Sensors Calibration . . . . . . . . . . . . . . . . . . . . . . . 6:64
Calibration Screen – Syringe Pump Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 6:66
Calibration Screen – Filter Clotting Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:68
Calibration Screen – Set Clock and Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:69
Calibration Screen – Screen Brightness Calibration . . . . . . . . . . . . . . . . . . . . . . 6:70
Calibration Screen – Pitch and Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:71
Calibration Screen – External Communication Interface . . . . . . . . . . . . . . . . . . 6:72
Calibration Screen – Therapy/Sets Configuration . . . . . . . . . . . . . . . . . . . . . . . . 6:73
Calibration Screen – Anticoagulation Configuration . . . . . . . . . . . . . . . . . . . . . 6:76
Calibration Screen – Anticoagulation Solutions . . . . . . . . . . . . . . . . . . . . . . . . . 6:78
Calibration Screen – Serial Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:84
Calibration Screen – Air Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:85
Calibration Screen – IP Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:86
Calibration Screen – Syringe Holder Configuration . . . . . . . . . . . . . . . . . . . . . . 6:87
Calibration Screen – Supplementary Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:88
Calibration Screen – Settings Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:90
Calibration Screen – Blood Warmer Configuration . . . . . . . . . . . . . . . . . . . . . . 6:92
Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:94
Final Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:97
7. Schematics
8. Specifications
Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Flow Rates and Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Blood Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Automatic Blood Return Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Replacement Solution/Fluid Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Dialysate Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
PBP Solution Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4
Patient Fluid Removal Performance / Patient Plasma Loss Performance . . . . 8:4
G5005209
Program version 7.xx
Effluent Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4
Syringe Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:5
Systemic, Prismaflex syringe pump anticoagulation method . . . . . . . . . . . . . 8:5
Citrate – Calcium, Prismaflex Syringe Pump anticoagulation method . . . . . . 8:6
TPE Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Pressure sensor range, accuracy and alarm limits . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7
Effluent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9
Air Bubble Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9
Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9
Alarm signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Audible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Sound pressure levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Visual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Physical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Weight, dimensions, etc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Scales Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Scale Weight Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Scale accuracy: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Line power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Battery backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:12
External communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:12
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13
Transportation and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13
Noise level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13
Vibration levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14
Fluid spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14
Cleanability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14
Electromagnetic Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14
Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
AC Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
Defibrillation-proof Applied Part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
Radio Frequency Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
Potential Equalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:20
Continuous Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:20
Conformity to International Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:21
Medical Device Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:22
Prismaflex® Disposable Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:23
CRRT Disposable Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:24
Low flow sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:24
Priming parameters and Blood flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:24
Patient fluid removal and Patient fluid loss/gain limit . . . . . . . . . . . . . . . . . . 8:24
Solution flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:25
Return Blood and Recirculation flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . 8:25
High flow sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:26
Priming parameters and Blood flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:26
Patient fluid removal and Patient fluid loss/gain limit . . . . . . . . . . . . . . . . . . 8:26
G5005209
Program version 7.xx
Solution flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:27
Return Blood and Recirculation flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . 8:27
TPE Disposable Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:28
Low flow sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:28
Priming parameters and Blood flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:28
Return Blood and Recirculation flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . 8:28
High flow sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:29
Priming parameters and Blood flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:29
Return Blood and Recirculation flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . 8:29
HP Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:30
Priming parameters and Blood flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:30
Return Blood and Recirculation flow rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:30
9. Equations
G5005209
Program version 7.xx
This page is intentionally left blank
G5005209
Program version 7.xx
Chapter 1
All available spare parts to be used for the Prismaflex control unit are
found in the illustrated Spare Parts List.
Filter
Depending on the therapy in use, Filter stands for either:
• Hemofilter/Dialyzer
• Plasmafilter
• Hemopurification cartridge
Manual
The term Manual refers to this Service Manual unless specified
differently.
Operator
In this manual, Operator designates appropriately trained and qualified
clinical staff who is in charge of the Prismaflex control unit. The
operator sets the prescribed values in accordance with the prescribed
treatment, responds to alarms, troubleshoots the Prismaflex control
unit, handles the bags, etc. Once the training material is read
through and understood, the operator is approved to operate the
Prismaflex control unit. The operator works within one meter from the
front of the Prismaflex control unit.
Responsible Organization
In this manual, Responsible Organization means a function or a person
who can identify, analyze, and control potential risks that could occur,
for example, when connecting the Prismaflex control unit to other
equipment or when making changes to the equipment connected to
the Prismaflex control unit.
Screens
The Prismaflex control unit displays different screens during operation.
Whenever a screen is referred to in this manual, it is identified by its
title, e.g. Enter Flow Settings screen or Status screen.
Training Material
The operator's manual is the primary training material for staff who is
to operate the Prismaflex system. See section “Competence of Service
Engineers” on page 1:5, for information concerning the minimum level
of competence required for service engineers.
Complaint
If a complaint is raised it shall be communicated to the relevant Gambro
Sales Company. In order for the Sales Company to be able to determine
the relevance of a complaint, it is of vital importance that the deviation
is communicated to them as comprehensive as the issue requires.
Safety Definitions
This manual uses the following safety definitions :
WARNING
A warning alerts the reader about a situation which, if not avoided,
could result in an adverse reaction, injury or death.
WARNING
CAUTION
A caution alerts the reader about a situation which, if not avoided,
could result in minor or moderate injury to the user or patient or
damage to the equipment or other property.
CAUTION
Technical Support
For technical support please contact your local Gambro Service
representative or visit the website.
Electrical Safety
Equipment applied part is Type BF, defibrillation - proof per IEC
60601-1.
Note: To be sure of the Prismaflex control unit’s classification see type
label found at the back of the Prismaflex control unit.
Fuse.
Information
Date of manufacture with year as four digits.
Catalog number.
Communication
Ethernet port.
Environmental
This symbol indicates that:
– since the equipment contains dangerous substances, it must be
recycled rather than disposed together with other municipal waste;
– the equipment was placed on the market after 13 August 2005.
Keep dry.
Solutions
Circle sign; placed as colored symbol on effluent scale and in the
graphical user interface in screens related to effluent. On the disposable
set the symbol is a relief shape in the plastic cover indicating the
effluent pump.
The CSA (C-US) mark indicates that the Prismaflex control unit
conforms to the requirements related to safety of medical devices for
the US and Canada. The “C” and the “US” adjacent to the CSA mark
indicate that the Prismaflex control unit has been evaluated to the
applicable ANSI/UL and CSA standards for use in the US and Canada.
The CCC mark indicates that the Prismaflex control unit conforms to
the safety requirements for China Compulsory Certification (CCC) as
described by the competent authority Certification and Accreditation
Administration of People's Republic of China (CNCA). The “S”
adjacent to the CCC mark indicates that safety requirements are met.
Disposal
The Prismaflex control unit shipping carton, foam packing, and
other packaging material should be disposed of according to local
regulations.
Pay attention to the fact that some components of the Prismaflex control
unit (display, batteries, circuit boards, etc.) may contain toxic
substances which, if released into the environment, pose a risk to the
health of living organisms and the environment itself.
Installation Guide
Contents
• Installation kit:
- 4 screws
• 20 ml syringe clip
• Pump crank
• Caution stickers
Space Requirements
The assembled Prismaflex control unit requires a minimum of 63 cm
× 63 cm (25 in × 25 in) of floor space. There must be enough space
around the Prismaflex control unit so that all fluid bags can hang freely
from the scale carrying bars.
Unpacking
1. Open the shipping carton. Carefully lift the Prismaflex control unit
out of the carton and place it upright. Carefully remove the foam
packing and pay attention not to damaging the Prismaflex control
unit components. Dispose of the shipping carton, foam packing,
and other packaging material according to local regulations.
Note: If the supplied power cord does not fit the wall socket, contact
an authorized electrician that can connect the power cord to the wall
socket.
2. Insert the power cord into the cable support, so that the cable
support fits tightly against the female connector of the power cord.
(A)
3. Turn the cable support by half a turn so that the cable support
guide is downward. (B)
4. Plug the power cord into the power cord socket on the rear panel
of the Prismaflex control unit.
5. Using the 4 screws provided, secure the cable support to the studs
on either side of the power cord socket. Tighten the screws using
the Torx T-20. (C)
2. Rotate the carrying bar so that the handle is pointing toward the
floor; close the scale.
Note: Scale will not close properly unless the handle of the carrying
bar is rotated toward the floor.
Perform the following steps to attach the caution labels to the front
panel:
1. Clean the area of Prismaflex control unit where the stickers are to
be placed according to point 3 in Visual Inspection and Cleaning
on page 6:15.
2. Place the sticker next to the handle of the Effluent scale and the
Replacement scale.
Note: The pictures on the stickers are not identical. Blue area on sticker
is to be facing towards the Effluent scale and the Replacement scale.
Perform the following steps to perform the change of the syringe clip:
2. Using the syringe pump hard keys, move the plunger to its bottom
position.
CAUTION
The installer is required to use an ESD (electro-static discharge)
Grounding Wrist strap during this procedure to avoid unintentional
damage to the electronic devices in the Prismaflex control unit.
Do not slide cards or IC's over any surface. Avoid plastic, vinyl
and Styrofoam in your work area.
CAUTION
Before first use of the Prismaflex control unit, the operations below
must be performed in Service mode by an authorized service technician
and recorded in the Maintenance Log (attached to the inside wall of
the rear panel).
1. Plug the power cord into the wall socket and turn on the
Prismaflex control unit.
Installation Test
Note: Read the Service’s Manual before performing the installation
test.
Before the first use of the Prismaflex control unit on a patient, the
installation test must be performed with a Prismaflex CRRT set in
place on the Prismaflex control unit. The installation test verifies that
the Prismaflex control unit is properly installed. The test is performed
using saline solution as a substitute for priming solution and fluid bags,
and a container of water as a substitute for the patient. Successful
completion of the installation test indicates that the Prismaflex control
unit is functioning properly.
Supplies needed:
• Catheter, 8F
4. Choose NO ANTICOAGULATION as
Anticoagulation Method.
5. Follow the instructions on the screen to load and prime the set. Use
saline solution as a substitute to priming and dialysate solutions.
The Prismaflex control unit performs multiple self-tests during
the priming cycle.
6. When the prime and the prime test are completed, press
CONTINUE. The Enter Treatment Settings screen
appears. Set the Loss/Gain Limit to 140 ml/3h. Press
CONFIRM ALL.
11. Note the hour and minute on the Status screen when the
Prismaflex control unit enters Run mode (this information can be
found in History screen, pressing EVENTS softkey).
14. Unclamp the access line and press the CONTINUE softkey
on the Warning screen. Verify that the alarm is cleared
(Warning screen leaves display, green light lit).
16. Press the OVERRIDE softkey. The Advisory screen leaves the
display, but remains in Examine Alarms. Yellow light is lit, the
Prismaflex control unit returns to the Status screen and the battery
icon, in the top right corner of the display, is lit.
17. Connect the power cord to the wall socket. Verify that the battery
icon disappears and that the Prismaflex control unit continues
in run mode. Verify that the alarm is cleared from the Examine
Alarms (press SYSTEM TOOLS softkey and verify that the
EXAMINE ALARMS softkey is not present) and green light lit.
18. Press the STOP softkey, then press the END TREATMENT softkey
and follow the instructions to unload the set.
19. In service mode, select Diagnose Screen – PM timer and Date. Set
and verify the PM timer.
3. Swing open the bracket mounted with protective and PIB board
to access the PC-board.
5. Turn on the machine and insert the software upgrade CD into the
CD-player.
10. When the software upgrade is complete a message “Press any key
to continue.” occurs.
12. Switch the main switch to OFF to restart the machine, wait 5
seconds and switch it ON again.
3. Set the SW1 (Dip Switch 1), on the Carrier board, to the ON
position.
6. Set the switch SW1 (Dip Switch 1), to the OFF position.
Technical Description
Contents
• Front Panel
• Rear Panel
• Interior Components
1. Dialysate/replacement 2 pump
CVVHD, CVVHDF: Pumps dialysate solution into the fluid
compartment of the filter.
2. Replacement pump
Pumps replacement solution/fluid into the blood flowpath.
6. Effluent pump
CRRT: Pumps ultrafiltrate/dialysate; automatically controls the
ultrafiltration rate, based on the operator-set patient fluid removal
rate, PBP, dialysate, replacement, and syringe flow rates (if
applicable).
7. Pump raceway
Tubing pathway within each peristaltic pump. The raceways accept
the pump segments of the Prismaflex disposable set.
8. Rotor
Center component of each peristaltic pump that rotates during pump
operation. Holds two rollers that occlude the pump segment in the
raceway. Occlusion moves the fluid in the pump segment forward
in discrete amounts and prevents backflow.
2. Tubing clips
Secure the blood lines going to the patient, including the PBP line.
Route tubing through clips closest to patient, according to color
coding.
3. Tubing guides
Hold the lines of the Prismaflex disposable set in correct position
on the control unit. The color of each tubing guide matches the
color of the line it holds.
4. Loader
Loads the Prismaflex disposable set.
7. Display
Shows text and softkeys. Provides operating, alarm, and help
instructions. Pressing the softkeys allows the operator to change
settings, start and stop functions, and navigate between screens.
8. Upper clip
Supports the calcium infusion line when performing “Citrate –
Calcium, Prismaflex syringe pump” anticoagulation method.
Temporarily holds the return line during setup of hemopurification
sets.
1. Speaker
Creates alarm sounds.
2. Fan
Provides continuous ventilation for the interior components of the
control unit.
3. Hour meter
Displays operating hours (cumulative time that power to the
Prismaflex control unit has been on).
5. Buzzer (inside)
Transmits a continuous buzz if a power loss occurs.
• Door
• Front
3. RS 232 board
Enables external serial data communication with the
Prismaflex control unit.
4. Memory board
Prismaflex control unit interface for the technical data card.
5. Ethernet board
Enables external Ethernet communication with the
Prismaflex control unit.
6. PIB board
Peripheral Interface Board. Contains the circuitry and connections
for the UABD, venous clamp, BLD and the pinch valves.
7. Log book
Update the Prismaflex control unit log book when the service is
performed.
2. Power supply
Supplies DC voltage to the Prismaflex control unit.
3. RAM memory
Internal memory for the PC 104 board.
4. PC 104 board
Control system CPU.
5. Compact flash
Placed on backside of PC 104 board, stores the Prismaflex software.
6. Carrier board
Interface for the PC 104 board.
7. Hour meter
Counts the total running hours of the Prismaflex control unit. Not
only the treatment hours.
2. Blood pump
Runs the Blood pump rotor.
4. Replacement pump
A stepper motor runs the slave pump rotor which rotates the
replacement pump.
5. Dialysate pump
A stepper motor runs the slave pump rotor which rotates the
dialysate pump.
6. Effluent pump
A stepper motor runs the slave pump rotor which rotates the
Effluent pump
7. Loader board
Controls the loader stepper motor.
9. Micro switch
Detection for completely loaded Prismaflex disposable set.
5. Pressure sensor
Fifth pod. Not used, for future therapy. Cable length 70 cm
7. Pressure transducer
Measures reference pressure for the ARPS (Automatic
Repositioning System).
8. ARPS pump
The pump is used for the ARPS and for adjusting the level in the
bubble trap.
2. Display
Graphical user interface.
6. Return clamp
The return clamp has two functions:
8. Pinch valve
The pinch valves open/close, depending on which therapy is
chosen, to allow pre- and post-filter options for delivery of
replacement solution.
9. CD-Rom player
CD/DVD reader
2. Battery, 24 V
Provides the possibility to proceed treatment during a power
failure. For more information see Power Failure on page 5:101.
3. Battery, 12 V
Not present in newer configurations of the Prismaflex control unit.
4. ARPS board
All pressure sensors and the ARPS valves are connected to this
board.
Internal Connections
The figures below shows the internal connections between boards.
• ARPS board
• PIB board
• Blood pump
• Syringe pump
• Loader
• Scales
• ABD assembly
• Pinch valves
• Venous clamp
• Pressure valves
• Pressure sensors
• Bar-code reader
• Remote alarm
• Hour meter
+24Vm 22.8V 25.2V 15A Positive 24V used as supply mainly to actuators. This
(shared voltage is enabled by the signal ENABLE_24Vm from
with the Protective CPU board. When the PSU is running on
currently battery in 24V mode (UPS mode) these limits can be
unused ignored and the voltage might follow the battery voltage
+24Vc) (max 1V below battery voltage)
+12Vout 11.9V 12.3V 4.0A Positive 12V used for supply of analogue parts as well
as the ARPS pump
+5Vd 5.1V 5.3V 6A Positive 5V generally used for digital circuitry
+5Vprot 5.1V 5.3V 5A Positive 5V used for digital circuitry in the protective
system and also used for miscellaneous digital circuitry
–5Va –5.4V –5.1V 2.0A Negative 5V used as supply to analogue parts
The system reference ground is in the power supply unit, and all
sub-system grounds originate from here to avoid ground loops as well
as power noise on sensor signals.
• GUI control
• Supervises all supply voltages (both from PSU and from ARPS)
• Supervises (directly) the speeds for Blood pump and Syringe pump
• Controls the valves between the ARPS pump and the pressure
sensors for access pressure, return pressure, filter pressure, effluent
pressure and auxiliary pressure
• Monitors the optical switch to detect that the blood line is present
in air bubble detector
• Controls and monitors the position of pinch valve for dialysate line
• Controls and monitors the position of pinch valve for infusion line
Monitoring of venous clamp +5VP, VCP, LVCS, GND Venous clamp detector board
I2C bus +5Vd, I2C_SDA, I2C_SCL, Protective CPU board and ARPS
GND board
The LVDS interface board converts the parallel digital LCD display
signals from the Control CPU into serial LVDS signals.
WARNING
The clinic/user is solely responsible for connecting a remote alarm
to the Prismaflex control unit and for verifying its function. If a
remote alarm is used, the operator is responsible for periodically
checking on the patient in person.
WARNING
Fluid pumps
The Dialysate pump, Effluent pump, Replacement pump and additional
PBP (Pre-blood pump) are all slave pumps with individual electronics
boards. These pumps are controlled through commands passed through
the I2C communication bus. Each pump has an unique I2C address
and this address is configured using jumpers on the intergrated circuit
board. The fluid pumps are responsible to control and monitor the
pump rotation direction and speed according to the commanded value.
Blood pump
The Blood pump is a slave pump with an individual electronics board.
The pump is controlled through commands passed through the I2C
communication bus. The Blood pump controls the pump rotation
direction and speed according to the commanded value.
Loader
The Loader handles the mounting of an attached line-set by pulling it
in position so that the fluid pumps and Blood pump can auto route the
pump segments into the slave pump runways.
Scales
The scales provides a reading of weight of the different fluid bags to
two different channels for the Control and Protective systems. Also
reporting to Protective that the bag holder is properly inserted into the
scale. All information is passed through I2C.
ABDA_ALM Logic TTL signal, PIB sends this signal PIB Protective
to protective when a macrobubble has
been detected.
TRBL_ALM Logic TTL signal, PIB sends this signal PIB Protective
to protective when trouble has been
detected, which means that the AGC has
not been able to control the amplitude of
the received signal.
ABD_Alm_Rst_A Logical TTL signal to clock the flip-flop Protective PIB
for air bubble detector alarm. Not active
status is high.
/APSTOP Logic TTL signal to enable the driver Protective P1, P2, P3, P4
stage of the pumps P1, P2, P3, P4 and and BLD
BLD.
TFT_VCC A delayed +5V power to the TFT. The LVDS_Tx board TFT
delay is controlled by a signal from
Control CPU; ENAVDD.
ENAVDD Digital signal TTL level controlling the Control CPU LVDS_Tx board
output power to the TFT.
BP_ENCODER Digital signal TTL level pulses indication Blood pump Protective
of Blood pump motor speed. (gear box
30:1)
ENABLEMOT Digital signal open drain to connect Protective Blood pump
the Blood pump motor to the driver
H-bridge. Low level connects the motor
to the bridge. Relay coil at motor is used
as pull-up.
TEST_BAT Digital open drain signal to activate Protective PSU
battery test by connecting a resistive load
to the back-up battery and monitoring
the resulting voltage across the battery.
Low level activates the test.
OUT_TBAT Digital TTL status signal for back-up PSU Protective
battery test. Low level during the test
indicates that the battery is charged.
High level indicates low battery voltage.
Function Check
Contents
• Initialization Tests
• Prime Self-Tests
• Periodic Self-Tests
1. BIOS Software
When the Prismaflex control unit is switched on, the Basic Input
Output Software (BIOS) of the PC104 is executed. The BIOS executes
a memory test on the PC104 board RAM and its ability to communicate
with hardware components.
During the initialization the boot file (bootrom.sys) is read and
executed from the first sector on the PC104's compact flash.
The system boots each of the boards in the Prismaflex control unit.
The following boards are initialized:
- Carrier Board
- Protective Board
When the boot file is finished being read the VxWorks application
program is initialized. VxWorks is a real time multi-tasking operating
system used to run the application program of the Prismaflex control
unit.
The VxWorks screen appears and the application programs begin to
load from the PC104's compact flash.
7. Start-up Conditions
- Protective Slave
- PIB Slave
- ARPS Slave
- Scales
The Protective system activates the Green, Yellow and Red LED
alternately. The buzzer is activated during this process. The
Prismaflex control unit has no internal monitoring for this process so
it is the responsibility of the operator to verify the correct operation
of this process.
a. Checksum Comparison
Checksum of each structure is compared to the software-calculated
checksum for that structure. Information structures stored on the
PC 104 compact flash and the Protective system processor are
verified for errors.
A checksum of the following information structures are
performed:
b. Range Check
Information structures which contain minimum and maximum
setting values are range checked to ensure the range is valid.
- Query screen
- Alarm screen
If an alarm occurs,see Alarms and Troubleshooting chapter for
details on how to remedy the alarm.
• Pre-prime
• Post-prime
Pre-Prime
The pre-prime phase includes ten subtests:
1. 24 V Battery-Up Test
Executes only when the Prismaflex control unit is equipped with
24V Battery Backup. The test is activated when the softkey
NEW PATIENT is selected. The protective system checks the limit
status of the voltage of the 24 V battery.
The Post-Prime tests are performed once the priming of the set occurs
and the service technician has pressed the PRIME TEST softkey on the
Priming X of X Cycles Complete screen.
2. BLD Normalization
3. BLD Test
3. BLD Test
Two seconds after a successful BLD normalization the BLD test is
performed. The transmitter PWM is lowered to a level simulating a
blood leak. The receiver value must be reduced to a value below 15000
within 5 seconds, which is equal to the detection of a blood leak.
The protective system then sends the commands START BP PUMP and
START FLUID PUMPS to the control system; all pumps must start.
The protective system then sends the commands STOP FLUID PUMPS
to the control system and checks that each fluid pump remain stopped
while the Blood pump is running.
The protective system then sends again the commands START BP
PUMP and START FLUID PUMPS to the control system and checks
that each pump run again.
The protective system then sends again the commands STOP BP
PUMP and STOP FLUID PUMPS to the control system and checks
that each pump remain stopped.
The protective system clears the ABD alarm signal.
The protective system checks that the trouble signal ABD has been
activated by the receiver hardware circuitry when the ABD transmitter
is first switched ON.
While the blood pump is turning, the protective system counts the
number of rotations required to achieve this pressure using the encoder.
The number of rotations must not be greater than a specific value
dependent on the selected disposable set.
The protective system reads the values of the filter, effluent and return
pressure sensors.
During this test the pressure pods are repositioned and the sensors are
checked in the following sequence:
a. Effluent pressure sensor
The access valve is then closed and the repositioning sequence of the
Filter pressure pod/sensor is started.
Note: If during the repositioning sequence the filter and ARPS pressure
sensor values differ by more than 20 mmHg for longer than 5 sec.
the valve closes and the verification/repositioning has failed. The
repositioning of this pod/sensor is skipped.
After the command to close the filter valve, the protective system
waits 15 seconds before verifying that the Effluent, Access and Filter
pressure sensors are within ±50 mmHg of their initial stored values.
For any pressure sensor that has failed the first repositioning sequence
the protective system will command that a new repositioning sequence
using the second repositioning algorithm be performed.
For the negative pressure pods (Effluent and Access) the ARPS pump
is commanded to run and remove air from the pod, pulling the pod
membrane towards the Prismaflex control unit until the protective
For the positive pod (Filter) the ARPS is commanded to pump air into
the pod, pushing the pod membrane away from the Prismaflex control
unit until the end of travel is detected.
Note: The Access pod is repositioned with the same process as the
Filter pod when the access pressure is positive.
Note: This test is performed even if there is not remote alarm connected
to the Prismaflex control unit. The service technician is responsible to
confirm if the remote alarm has been activated.
Flow Rates can be read from the Flow settings field and Anticoagulation
field of the Status screen. History information can be read from the
History screen. A complete periodic self-test takes approximately
1 to 6 minutes. Once started, its progress is signalled to the operator
through messages on the Status screen. Certain functions, including
adjustments to treatment parameters, are unavailable during an ongoing
test and the related softkeys are gray. Any treatment interruptions via
the STOP softkey should be avoided during an ongoing test in order to
allow for its swift and successful completion.
Note: The information icon “i” on the Status screen is lit with an
orange color during self-test.
If any of the subtests fail, the ongoing run of the periodic self-test is
terminated and a Malfunction: Self-test Failure alarm occurs. The
alarm screen identifies the failed subtest and provides instructions for
the operator.
Parameter Description
PBP. TACH. Value, in rpm, of the PBP Pump speed read by the Protective side
EFFL. TACH. Value, in rpm, of the Effluent Pump speed read by the Protective side
DIAL. TACH. Value, in rpm, of the Dialysate Pump speed read by the Protective
side
REPL.TACH. Value, in rpm, of the Replacement Pump speed read by the
Protective side
BLOOD.TACH. Value, in rpm, of the Blood Pump speed read by Protective side
PBP. SET. Value, in rpm, of the PBP Pump speed set by the Control side
EFFL. SET. Value, in rpm, of the Effluent Pump speed set by the Control side
DIAL. SET. Value, in rpm, of the Dialysate Pump speed set by the Control side
REPL.SET. Value, in rpm, of the Replacement Pump speed set by the Control
side
BLOOD.SET. Value, in rpm, of the Blood Pump speed set by the Control side
PBP. MOTOR. PBP Pump Motor status. Possible values displayed are:
Enable/Disable
BLOOD. SENS. A. Number of pulses accumulated for the hall sensor B of the Blood
Pump
PBP. SENS. B. Delay between the time in which the magnet (on the PBP Pump
rotor) closes the circuit of the sensor A and the time in which the
magnet closes the circuit of the sensor B
EFFL. SENS. B. Delay between the time in which the magnet (on the Effluent Pump
rotor) closes the circuit of the sensor A and the time in which the
magnet closes the circuit of the sensor B
DIAL. SENS. B. Delay between the time in which the magnet (on the Dialysate Pump
rotor) closes the circuit of the sensor A and the time in which the
magnet closes the circuit of the sensor B
REPL. SENS. B. Delay between the time in which the magnet (on the Replacement
Pump rotor) closes the circuit of the sensor A and the time in which
the magnet closes the circuit of the sensor B
BLOOD. SENS. B. Delay between the time in which the magnet (on the Blood Pump
rotor) closes the circuit of the sensor A and the time in which the
magnet closes the circuit of the sensor B
EFFL. T. AB Delay between the time in which the magnet (on the Effluent Pump
rotor) closes the circuit of the sensor A and the time in which the
magnet closes the circuit of the sensor B
DIAL. T. AB Delay between the time in which the magnet (on the Dialysate Pump
rotor) closes the circuit of the sensor A and the time in which the
magnet closes the circuit of the sensor B
REPL. T. AB Delay between the time in which the magnet (on the Replacement
Pump rotor) closes the circuit of the sensor A and the time in which
the magnet closes the circuit of the sensor B
BLOOD. T. AB Delay between the time in which the magnet (on the Blood Pump
rotor) closes the circuit of the sensor A and the time in which the
magnet closes the circuit of the sensor B
PBP. T. BA Delay between the time in which the magnet (on the PBP Pump
rotor) closes the circuit of the sensor B and the time in which the
magnet closes the circuit of the sensor A
EFFL.T. BA Delay between the time in which the magnet (on the Effluent Pump
rotor) closes the circuit of the sensor B and the time in which the
magnet closes the circuit of the sensor A
DIAL. T. BA Delay between the time in which the magnet (on the Dialysate Pump
rotor) closes the circuit of the sensor B and the time in which the
magnet closes the circuit of the sensor A
REPL. T. BA Delay between the time in which the magnet (on the Replacement
Pump rotor) closes the circuit of the sensor B and the time in which
the magnet closes the circuit of the sensor A
BLOOD. T. BA. Delay between the time in which the magnet (on the Blood Pump
rotor) closes the circuit of the sensor B and the time in which the
magnet closes the circuit of the sensor A
PBP. BRAKE. Not used
EFFL. BRAKE. Not used
DIAL. BRAKE. Not used
REPL.BRAKE. Not used
BLOOD.BRAKE. Status of the break on the Blood Pump. Possible values displayed
are: Enabled/Disabled
PBP. AL. S. A Not used
BLOOD. ENCODER. Value, in rpm, of the Blood Pump speed read by Control side
SC. PBP. CTR AD PBP scale A/D value read by the Control side
SC. EFF. CTR AD Effluent scale A/D value read by the Control side
SC. DIA. CTR AD Dialysate scale A/D value read by the Control side
SC. REP. CTR AD Replacement scale A/D value read by the Control side
SC. PBP. PRT AD PBP scale A/D value read by the Protective side
SC. EFF. PRT AD Effluent scale A/D value read by the Protective side
SC. DIA. PRT AD Dialysate scale A/D value read by the Protective side
SC. REP. PRT AD Replacement scale A/D value read by the Protective side
SC. PBP. REFAD1. PBP scale A/D reference 1 value (1st A/D channel)
SC. EFF. REFAD1. Effluent scale A/D reference 1 value (1st A/D channel)
SC. DIA. REFAD1 Dialysate scale A/D reference 1 value (1st A/D channel)
SC. REP. REFAD1 Replacement scale A/D reference 1 value (1st A/D channel)
SC. PBP. REFAD2. PBP scale A/D reference 2 value (2nd A/D channel)
SC. EFF. REFAD2. Effluent scale A/D reference 2 value (2nd A/D channel)
SC. DIA. REFAD2. Dialysate scale A/D reference 2 value (2nd A/D channel)
SC. REP. REFAD2. Replacement scale A/D reference 2 value (2nd A/D channel)
SC. PBP. CTR GR Weight in grams, on the PBP scale, read by the Control side
SC. EFF. CTR GR Weight in grams, on the Effluent scale, read by the Control side
SC. DIA. CTR GR Weight in grams, on the Dialysate scale, read by the Control side
SC. REP. CTR GR Weight in grams, on the Replacement scale, read by the Control side
SC. PBP. PRT GR Weight in grams, on the PBP scale, read by the Protective side
SC. EFF. PRT GR Weight in grams, on the Effluent scale, read by the Protective side
Parameter Description
ACC. AD VAL Access pressure A/D value acquired by the transducer
FIL. AD VAL Filter pressure A/D value acquired by the transducer
EFF. AD VAL Effluent pressure A/D value acquired by the transducer
5TH. AD VAL 5th Pod pressure A/D value acquired by the transducer
ARPS. AD VAL Circuit pressure A/D value acquired by the ARPS
RET. AD VAL Return pressure A/D value acquired by the transducer
ACC. PRES. Access pressure value read by the Protective side
5TH. PRES. 5th Pod pressure value read by the Protective side
ARPS. PRES. ARPS circuit pressure read by the Protective side
RET. PRES. Return pressure value read by the Protective side
ACC. VALVE. Access valve status. Possible values displayed are:
Open/Closed
FIL. VALVE. Filter valve status. Possible values displayed are: Open/Closed
ARPS. REFAD1. ARPS A/D reference 1 value read by the Protective side
ARPS. REFAD2. ARPS A/D reference 2 value read by the Protective side
ARPS. REFAD3. ARPS A/D reference 3 value read by the Protective side
ABD. LINE. Presence of line in the ABD. Possible values displayed are:
Line Detected/Not detected
ABD. TROUB. Malfunction detected in the ABD circuit. Possible values displayed
are: ON/OFF
ABD. MAC.B. Macro Bubble detected by the ABD. Possible values displayed are:
ON/OFF
ABD. APSTOP. Not used
H.PUMP. MANUAL. Activation of the Manual mode of the Syringe Pump. Possible values
displayed are: Enabled/Disabled
H.PUMP. AUTOM. Activation of the Automatic mode of the Syringe Pump. Possible
values displayed are: Enabled/Disabled
Parameter Description
CLAMP. POS. Return clamp status. Possible values displayed are:
Open/Closed
PIN.PP POS. Lower pinch valve position. Possible values displayed are:
Pre/Neutral/Post/Undefined
PIN.DP POS. Upper pinch valve position. Possible values displayed are:
Pre/Neutral/Post/Undefined
CLAMP. CL.COM. Comment sent by the Control side to the Return clamp. Possible
values displayed are: Open/Closed
PIN.PP CL.COM. Not used
PIN.DP CL.COM. Not used
CLAMP. LINE. Line presence in the Return line clamp. Possible values displayed
are: Line Detected/Not detected
PIN.PP LINE. Not used
PIN.DP LINE. Not used.
BLD. TX.ON BLD A/D value read when the transmitter is ON
BLD. TX.OFF BLD A/D value read when the transmitter is OFF
BLD. PWM. PWM value
VOLTAGE CT24V Status of the +24V relay in the Power supply (Enabling/Disabling
done by the Control side). Possible values displayed are: OFF/ON
VOLTAGE PT24V Status of the +24V relay in the Power supply (Enabling/Disabling
done by the Protective side). Possible values displayed are:
OFF/ON
LOADER. SWITCH. Status of the switch of the Prismaflex disposable set loader. Possible
values displayed are: Loaded / Not Loaded
REM.OUT STAT. Status of the remote alarm output. Possible values displayed
are: Enabled/Disabled
EXT.I2C STAT. Not used
Parameter Description
Tare method Empty Bag Method set in Custom mode. Possible values displayed
are: variable/fixed
Meas_tare weight Measured tare weight in grams.
Tare weight Tare weight in grams as calculated/established by Protective.
Tare min Minimum tare in grams as calculated/established by Protective.
Tare max Maximum tare in grams as calculated/established by Protective.
Bag volume Allowed bag volume in ml as set in Custom mode or from Change
Bags or Change Bags/Containers screen.
Bag weight Bag weight in grams as measured by Protective at last tare
calculation.
Change bag min Minimum weight in grams for a new bag.
Change bag max Maximum weight in grams for a new bag.
Parameter Description
SWVERS. CONTROL. Software version of the Control System.
SWVERS. PLD. Software version of the PLD Board
SWVERS. CH.PRO. Software version of the Carrier Board
SWVERS. PROT. Software version of the Protective Board
SWVERS. P.INF. Not used
SWVERS. BLOOD. Old Pump: Not currently used. New Pump: Software version of
the Blood Pump
SWVERS. SCALE. Not used
SWVERS. ARPS. Software version of the ARPS Board
SWVERS. PIB. Software version of the PIB Board
Bar code
The bar code contains information about the setup and configuration of
the machine, such as hardware/software configuration and calibration
parameters.
WARNING
When responding to any alarm, carefully follow the instructions on
the displayed alarm screen and its associated Help screen.
To clear some alarms, the Prismaflex control unit must override the
alarm for a brief time (60 seconds). The alarm screen notifies the
operator that the alarm will be overridden if the OVERRIDE softkey
is pressed. A new alarm for the same condition cannot occur during
the override period. Therefore, carefully observe the set and all
operation during the override period. If the alarm condition is still
present after the override period, the Prismaflex control unit issues
a new alarm.
Operator Response
The Warning screen gives the operator instructions for responding
to the Warning alarm. Appropriate responses are different for each
warning.
• Blood pump restarts and return line clamp opens. Seven seconds
later, other pumps restart.
• Blood pump restarts and return line clamp opens. Seven seconds
later, other pumps restart.
When the override period is complete, the alarm either clears or recurs.
Operator Response
Some malfunctions can be cleared by the operator; others require
service by an authorized service technician. The Malfunction
screen gives instructions for responding to the Malfunction alarm.
Appropriate responses are different for each malfunction.
• Blood pump restarts and return line clamp opens. Seven seconds
later, other pumps restart.
• Blood pump restarts and return line clamp opens. Seven seconds
later, other pumps restart.
When the override period is complete, the alarm either clears or recurs.
• Blood and syringe pumps continue to operate and the return line
clamp remains open. The patient’s blood continues to circulate
through the blood flowpath, but treatment is suspended.
Operator Response
The Caution screen gives the operator instructions for responding to the
Caution alarm. Appropriate responses are different for each caution.
Operator Response
The Advisory screen gives the operator instructions for responding
to the Advisory alarm; appropriate responses are different for each
advisory.
The priority for each alarm is shown in the Alarm Priority List.
The operator can press EXAMINE ALARMS to view the list of pending
alarms.
6 Air in Blood
7 Return Disconnection
8 Return Pressure Dropping
9 Set Disconnection
10 Filter Clotted
11 Plasmafilter Clotted
12 HP Cartridge Clotted
13 Blood Leak Detected
14 Access Extremely Negative
15 Return Extremely Positive
Warnings
Malfunctions
42 Air Detector
43 Clamp Stuck Closed
44 Blood Pump
45 Effluent Pump
46 Replacement Pump
47 Dialysate Pump
48 Replacement 2 Pump
49 PBP Pump
50 Normalization Failed
51 Blood Leak Detector
52 Self-Test Failure
53 Prime Self-Test
54 Syringe Pump
55 Scales
56 Pressure Zero Test
57 Scale Zero Test
58 Checksum Interrupted
59 Custom Data
60 Library Data
61 Cannot Save Custom Data
62 Memory Error
63 Upper Pinch Valve
64 Lower Pinch Valve
65 Scales Circuit Board
66 Effluent Scale Sensor
67 Replacement Scale Sensor
68 Dialysate Scale Sensor
69 PBP Scale Sensor
70 Syringe Not Loaded / Ca Syringe Not Loaded
71 Line in Air Detector
72 Line in Clamp
73 No Line in Air Detector
74 No Line in Clamp
75 Memory Error, code 7
76 Auto Blood Return
Caution
Advisory
90 Check Access
91 Check Return
92 Blood Flow Stopped
93 Syringe not loaded / Ca Syringe Not Loaded
94 Fluid Pumps Stopped
95 Check Syringe Line
96 Syringe Empty
97 Syringe Line Clamped
98 Calcium Syringe Empty
99 Syringe Almost Empty / Ca Syringe Almost Empty
100 Calcium Line Clamped
101 Ca Line Not Connected
102 Filter is Clotting
103 Plasmafilter is Clotting
104 HP Cartridge is Clotting
105 TMP Too High
106 TMPa Too High
107 Time to Change Set
108 Cannot Detect Return
Observation:
Alarm occurs if the access pressure is more negative than the user-controllable
“Access Extremely Negative” Warning Limit. or if access pressure is 150 mmHg or
more below its operating point.
Note: An operating point is the pressure value when the pressure is considered stable
after an event such as an alarm, change of blood flow, etc.
This alarm self-clears if pressure goes back to normal limits within 15 secondsc.
During the self-clear time the monitor will not give an audible alarm.
Blood flow rate too high for the Check Access pressure in Diagnose Screen
access device. – Pressure Pod Reposition on page 6:30.
If pressure deviation in diagnose, see next
Service action.
Observation:
Alarm occurs if the access pressure is more positive than the user-controllable
“Access Extremely Positive” Warning Limit.
Blood flow rate has been set too Increase blood flow rate. Return to alarm
low according to the blood pressure screen and press CONTINUE.
delivered by the external device.
Blood flow rate too low for the Check Access pressure in Diagnose Screen
external device. – Pressure Pod Reposition on page 6:30.
If pressure is correct, check Blood pump
flowrate in Service Diagnose, Diagnose
Screen – Pumps Diagnose on page 6:26.
If value is incorrect, replace the Blood
pump. If value is correct, continue with
pressure sensors.
Air in Blood
Disconnected line, leaking Check blood access and set for possible
connection, set not fully primed, leakage or disconnection.
return line not installed in air Remedy possible causes.
detector.
Press Up arrow until return pressure is
NEGATIVE. If unsuccessful, proceed with
manual procedure.
Bag/Container Empty
Observation:
This alarm appears during priming only.
Observation:
Valid only if Variable Empty Bag method is selected.
Amount of fluid in the identified Choose one of the three options on the
solution bag does not match the alarm screen.
current Allowed Volume. Caution:
Choose KEEP BAG only to use a partially
full bag that is of the same total volume
capacity as the current Allowed Volume.
Battery Low
Observation:
Main power is still out and batteries are out of energy.
Applicable when machine configuration includes the back-up battery (check with the
local representative for more information). See Power Failure on page 5:101
Machine is unplugged and battery Connect power cord. Press STOP and
is out of energy. select RESUME to restart the treatment.
Effluent line not properly installed Press line into detector from the bottom up
in blood leak detector. and route securely through tubing guides.
Press OVERRIDEa. After alarm clears,
press Normalize BLD in System Tools
screen and follow instructions.
Leak in filter membrane. Change the set via STOPb. Send sample of
the effluent to blood lab for a cell count.
The calcium infusion line is Unclamp the calcium infusion line. Press
clamped. CONTINUE.
Observation:
This alarm appears during priming only.
The calcium infusion line is not Connect a dedicated calcium infusion line
connected to the syringe. to the syringe. Press CONTINUE.
The unused and stowed syringe line Clamp the unused line on the disposable set
on the disposable set is connected and leave it unused during entire treatment
to the calcium syringe. when “Citrate – Calcium, Prismaflex
Syringe Pump” method is chosen. Press
CHANGE SYR/LINE softkey and follow
the instructions on the screen to connect
a dedicated calcium infusion line to the
syringe.
Crossed Lines
The lines are crossed or tangled. Check and correct lines and bags setup.
Press REPRIME.
One or more scales failed. Press DISCONNECT, turn off the machine.
Call service.
Observation:
This alarm appears during priming only.
Observation:
Effluent Bag volume does not match Allowed Volume.
Cause: a 5000 ml empty bag is hung on scale while Effluent Allowed Volume is
9000 ml.
A 5000 ml empty bag is hung on Replace the 5000 ml bag hung on the
the scale while Effluent Allowed scale with a 9000 ml bag or change the
Volume is 9000 ml. Effluent Allowed Volume by pressing
MODIFY BAG. Press CONTINUE.
Effluent line of new set is not Remedy and press RETEST. If alarm
installed in blood leak detector. recurs, press DISCONNECT and load a
new set. If alarm recurs with a new set,
call for service.
Blood leak detector failed. Check the function of the Blood leak
detector in Diagnose Screen – BLD (Blood
Leak Detector) on page 6:43.
If malfunction, replace the Blood leak
detector.
Filter Clotted
Observation:
Filter pressure drop exceeds limit for the filter in use, or both the “Filter is Clotting”
Advisory and the “TMP Excessive” Caution limits are reached.
Note: TMP value in the MARSFLUX filter is not considered for this alarm during
CRRT MARS therapy; see section “Pressure management” in Prismaflex Operator´s
manual.
Clots have formed in the filter. Change the set via STOPb. Test
Note: Clotting is usually due to patient’s clotting parameters and adjust
inadequate anticoagulation of the anticoagulant delivery if needed.
blood flowpath.
Ultrafiltration rate is too high for Press CONTINUE and then reduce
filter in use. replacement solution flow rate and/or PBP
solution flow rate and/or patient fluid
removal rate.
During "Citrate - Calcium" Press STOPb and change the set. Ensure
anticoagulation: that PBP pump works properly. If PBP
Citrate delivery has failed. pump has failed, call service.
During CRRT MARS treatment: If blood leak confirmed, press STOP and
The MARS monitor has detected change the set. If not, troubleshoot the
a blood leak. MARS monitor and press CONTINUE.
Observation:
Alarm occurs if filter pod pressure is ≥450 mmHg.
The filter pressure will drop as operation commences. (The appropriate Advisory or
Warning alarm occurs when filter clotting becomes problematic.)
Note 2: If the above operator responses do not clear this alarm, the set can be changed
via STOPb. If alarm recurs with new set, end treatment via STOPb. Call service.
Filter pressure sensor failed. End treatment via STOPb. Call service.
During CRRT MARS treatment: If blood leak confirmed, press STOP and
The MARS monitor has detected change the set. If not, troubleshoot the
a blood leak. MARS monitor and press CONTINUE.
Observation:
Filter pressure drop exceeds limit for the HP cartridge in use.
Clots have formed in the HP Change the set via STOPb. Test
cartridge. patient’s clotting parameters and adjust
Note: Clotting is usually due to anticoagulant delivery if needed.
inadequate anticoagulation of the
blood flowpath.
Loading Error
Observation:
Not possible to load/unload the set.
Pinch valves position not correct. Press RETEST to reposition the pinch
valves and clear the alarm.
Observation:
Filter pressure drop exceeds limit for the plasmafilter in use, or both the “Plasmafilter
is Clotting” Advisory and the “TMPa Excessive” Caution limits are reached.
Clots have formed in the Change the set via STOPb. Test
plasmafilter. patient’s clotting parameters and adjust
Note: Clotting is usually due to anticoagulant delivery if needed.
inadequate anticoagulation of the
blood flowpath.
Ultrafiltration rate is too high for Press CONTINUE and then reduce
filter in use. replacement solution flow rate and/or
patient plasma loss rate.
During "Citrate - Calcium" Press STOPb and change the set. Ensure
anticoagulation: that PBP pump works properly. If PBP
Citrate delivery has failed. pump has failed, call service.
Observation:
Power lost for more than 15 seconds after machine entered Run mode.
Recirculation Time has exceeded Press STOP RECIRC. and resume the
the manufacturer-set limit. treatment.
Return Disconnection
Observation:
Alarm occurs if return pressure is lower than +10 mmHg and the return pressure
operating point is higher than +10 mmHg. The alarm reoccurs if the following return
pressure operating point is lower than +10 mmHg.
Alarm also occurs once if the operating point is lower than +10 mmHg after an
operator induced (re)start of the blood pump. Should this pressure condition persist,
it will be indicated by subsequent Advisory Cannot Detect Return alarms.
Note: An operating point is the pressure value when the pressure is considered stable
after an event such as an alarm, change of blood flow, etc.
Return pressure sensor failed. End treatment via STOPb. Call service.
Fluid barrier wet with new set. Check the pressure sensors and the
pressure ARPS circuit for leakage
in Diagnose Screen – Pressure Pod
Reposition on page 6:30. If leakage is
detected, remedy the pressure sensor,
pressure valves, ARPS pump alt ARPS
circuit.
If pressure deviation in diagnose, see next
Service action.
Observation:
Alarm occurs if return pressure is more positive than the user-controllable “Return
Extremely Positive” Warning Limit.
This alarm self-clears if pressure goes back to normal limits within the self-clear time
and the monitor will not give an audible alarm.
Return line clamped or kinked. Remedy, and wait for self-clearing attempt
Observation:
This alarm occurs if return pressure is 50 mmHg or 70 mmHg (with blood
flow>200ml/min) below its operating point.
The hydrophobic membrane is wet, Press STOPb and use CHANGE SET to
and/or service line is disconnected. load/prime a new set. If fluid barrier gets
wet again with a new set, call service.
Return pressure sensor failed. End treatment via STOPb. Call service.
During CRRT MARS treatment: If blood leak confirmed, press STOP and
The MARS monitor has detected change the set. If blood leak not confirmed,
a blood leak. troubleshoot the MARS monitor and press
CONTINUE.
Fluid barrier wet with new set. Check the pressure sensors and the
pressure ARPS circuit for leakage
in Diagnose Screen – Pressure Pod
Reposition on page 6:30. If leakage is
detected, remedy the pressure sensor,
pressure valves, ARPS pump alt ARPS
circuit.
If pressure deviation in diagnose, see next
Service action.
Scale Open
Observation:
This alarm appears during priming only.
Impeding object blocking scale Inspect and remedy possible causes. Press
from fully closing, bag improperly scale toward machine until it locks into
positioned on hooks, carrying bar closed position. Press CONTINUE.
not centred on bar tray or handle
not rotated down (toward floor).
Observation:
Alarm occurs if filter pressure is lower than +10 mmHg and the filter pressure
operating point is higher than +10 mmHg.
Filter pressure pod not installed or Clean pod from debris and reinstall pod
debris in sensor housing. as applicable. Press OVERRIDE to clear
alarm and perform self-test through
SYSTEM TOOLS as to reposition pod
membrane. If the pod problem recurs,
press STOP to change the set. If alarm
recurs with new set, end treatment and call
service.
Line between blood pump and filter Make sure the line is securely connected.
is disconnected. To resume treatment, press OVERRIDEa.
Blood flow rate too low for the Increase the blood flow rate and press
access device. OVERRIDEa.
Filter pressure sensor failed. End treatment via STOPb. Call service.
Return line disconnection and Check return line and catheter; remedy
failure of return pressure alarm. as applicable. If fluid barrier wet,
press STOP and press CHANGE SET to
load/prime a new set.
If fluid barrier is not wet, press
OVERRIDEa to clear alarm and to reach
Status screen. Press SYSTEM TOOLS and
perform self-test in order to check return
pressure sensor.
Blood flow rate too low for the Check Filter pressure in Diagnose Screen
access device. – Pressure Pod Reposition on page 6:30.
If pressure deviation in diagnose, check
the pressure sensors and pressure ARPS
circuit for leakage in Diagnose Screen –
Pressure Pod Reposition on page 6:30.
If leakage is detected, remedy the pressure
pod sealing cones, the pressure sensor,
pressure valves, ARPS pump alt ARPS
circuit.
If pressure is correct, check Blood pump
flowrate in Service Diagnose, Diagnose
Screen – Pumps Diagnose on page 6:26.
If value is incorrect, replace the Blood
pump.
Set-up Error
Observation:
Alarm occurs if pre-prime self-test fails.
Syringe Empty
Syringe line clamped, kinked or Inspect syringe line; remove any clamps,
obstructed. kinks or other obstruction. Press
CONTINUEa.
Unsuitable Ca solution
Observation:
Alarm occurs after Confirm Loaded Set screen if no valid set of initial
flow settings with reasonable operating ranges is available when using the selected
calcium solution. See the chapter about anticoagulation in Operators manual. Alarm
screen indicates if selected calcium solution is too diluted or too concentrated.
Observation:
This set cannot be used with the therapy selected.
Failure of recognition test. Check that the set matches the selected
therapy.
Verify physician prescription for the
therapy and set.
Press UNLOAD to access the
Load Set Screen.
If needed, press CANCEL on the
Load Set Screen, select the
prescribed therapy, then load the
prescribed set.
If needed, remove the set attached to the
control unit (wrong set), then load the
prescribed set.
Note: If alarm occurs repeatedly, do not
use the machine until repairs are made.
Mix up of high flow and low flow If loaded set does match set identified on
set after Bar Code Reading Failure. screen, press CONFIRM. Otherwise, press
At the end of the first priming DISCONNECT and reload set.
cycle in case of “Bar code reading
failure”, the operator has to
verify that the loaded set and the
prescribed set are the same, by
pressing CONFIRM.
Return line not connected to If loaded set does match set identified on
effluent bag or effluent bag cock screen, press CONFIRM. Otherwise, press
opened. DISCONNECT and reload set.
Anticoagulation Suspended
Observation:
Citrate infusion is stopped because calcium infusion has been interrupted for too
long. Citrate – Calcium anticoagulation is suspended. This alarms self-clears once
anticoagulation is resumed.
Bag Empty
Observation:
Variable Empty Bag method is selected, and amount of fluid in bag does not match
Allowed Volume.
Amount of fluid in the identified Choose one of the options on the alarm
solution bag does not match the screen.
current Allowed Volume.
Caution:
Choose KEEP BAG only to use a partially full bag that is of the same total volume
capacity as the current Allowed Volume.
Observation:
Effluent Bag volume does not match expected volume.
A 5000 ml empty bag is hung on Replace the 5000 ml bag hung on the
the scale while Effluent Allowed scale with a 9000 ml bag or change the
Volume is 9000 ml. Effluent Allowed Volume by pressing
MODIFY BAG. Press CONTINUE.
Flow Problem
Observation:
Flow problem detected with fluid indicated on screenc.
Effluent drain port not fully closed. Remedy and press CONTINUE.
Bag connector not firmly tightened, Make sure the Luer connector is firmely
if bag connected through Luer. tightened.
Incorrect puncture of the bag, if Using aseptic technique to make sure that
bag connected through spike. the solution bag is correctly punctured.
Air bubbles in the solution bag or Check bag connections. Remedy and press
line. CONTINUE.
Air bubbles in the effluent fluid. Check effluent line for kink between pod
and pump. Remedy and press CONTINUE.
Non breathing spike used with a Replace the non breathing spike with a
rigid container. breathing spike. Press CONTINUE.
Line connected to wrong bag or Make sure that the line is connected to the
bag on wrong scale. correct bag. Color-coding of line must
match color of used scale.
Non-occlusive pump or scale Press STOP and end the treatment. Call
failure. service.
Observation:
The Unintended Patient Fluid Gain exceeded the selected limit and the treatment was
therefore permanently suspended for safety reasons. Fluid pumps are stopped and
will not re-start; the blood pump continues to run.
A flow problem has caused the Press STOP and end the treatment. If
Prismaflex control unit to infuse indicated, restart treatment with a new set.
excess fluid to the patient: Use HISTORY to verify exact fluid
Repeated flow obstructions due to exchange status at STOP time.
closed clamps or kinked lines;
Flow errors due to incorrect use of
the acccess port on the effluent bag.
Observation:
The Unintended Patient Fluid Loss exceeded the selected limit and the treatment was
therefore permanently suspended for safety reasons. Fluid pumps are stopped and
will not re-start; the blood pump continues to run.
A flow problem has caused the Press STOP and end the treatment. If
Prismaflex control unit to pull indicated, restart treatment with a new set.
excess fluid from the patient: Use HISTORY to verify exact fluid
Repeated flow obstructions due to exchange status at STOP time.
closed clamps or kinked lines;
Flow errors due to incorrect use of
the access port on a solution bag
(PBP, dialysate, replacement);
Flow errors due to effluent fluid
degassing.
PBP fluid input has reached the Stop PBP infusion and continue therapy
maximum allowed Patient Fluid without further patient fluid gain: Press
Gain for the therapy/set. FLOW SETTINGS, set PBP rate to zero.
Continue therapy with further fluid gain for
the patient: Press CONTINUE. Alarm will
recur when Patient Fluid Gain increases
10% beyond the maximum allowed value.
End treatment: Press STOPb.
Scale Open
Observation:
Scale not properly closed.
Impeding object blocking scale Inspect and remedy possible causes. Press
from fully closing, bag improperly scale toward machine until it locks into
positioned on hooks, carrying bar closed position. Press CONTINUE.
not centred on bar tray or handle
not rotated down (toward floor).
TMPa Excessive
Observation:
Access transmembrane pressure exceeds the safe limit.
Effluent rate is too high. Too much Decrease the replacement fluid or increase
plasma is being removed. blood flow rate. Return to alarm screen,
(Effluent rate = patient plasma loss press CONTINUE.
rate + replacement fluid rate)
TMP Excessive
Observation:
Transmembrane pressure exceeds membrane pressure limit.
Inadequate anticoagulation of the Press STOP and change the set or test
extra corporeal circuit. patient’s clotting parameters and adjust
anticoagulant delivery if needed.
Note: Filter Clotted warning occurs when
the blood in the filter is clotted.
Observation:
Prescribed Total Replacement Volume has been delivered.
Observation:
Too many attempts to remedy Caution: Flow Problem alarms. Accuracy of patient
fluid removal may be compromised.
Clearing attempts have exceeded Press STOP and end the treatment. If
the manufacturer-set limit of 10 indicated, restart treatment with a new set.
tries in 3 hours. Use HISTORY to verify exact fluid
exchange status at STOP time.
Battery Exhausted
Observation:
Applicable when machine configuration includes the back-up battery (check with the
local representative for more information).
Appears when the power level of the back-up battery is too low.
Alarm recurs due to old battery or Leave the machine on or operate for more
broken internal wiring. than 24 hours.
If the alarm does not self-clear within 24
hours, call service.
Alarm recurs due to old battery or Check the connection battery wiring.
broken internal wiring. Remedy, if necessary. Check the recharge
capacity of the battery. If malfunction,
replace the battery.
Observation:
Machine has been left in the Stop screen for 60 seconds.
Machine left in the Stop screen for Inspect blood flowpath for signs of
more than 60 seconds (all pumps clotting. If clotted, change the set.
stopped). Press CONTINUE to clear alarm and
return to the Stop screen, then choose
CHANGE SET.
If flowpath not clotted, press
CONTINUE to clear alarm and return to
the Stop screen.
The central venous access on the Unclamp the central venous access on the
patient is clamped. patient.
The central venous access on the Check patient access patency for potential
patient is obstructed by clots or obstructions. Consult a physician for
sticks fast to the intima of the vein. assessment of the central venous catheter.
The unused syringe line on the Clamp the unused syringe line on the
disposable set is connected to the disposable set and left unused during
calcium syringe. entire treatment when “Citrate – Calcium,
Prismaflex Syringe Pump” method is
chosen. Press CHANGE SYR/LINE softkey
and follow the instructions on the screen
to connect a dedicated calcium infusion
line to the syringe.
Observation:
This alarm occurs when the return pressure operating point is more negative than
+10 mmHg.
Machine is unable to detect return line and catheter disconnections.
Catheter size too large or blood If catheter size is too large for the
flow too low. prescribed blood flow rate, consider to
change to a smaller catheter.
If compatible with prescription, press
FLOW SETTINGS and increase the blood
flow rate. When back in the alarm screen,
press OVERRIDE.
Chamber monitor line not securely If the fluid barrier is not damaged, secure
connected to return pressure port. monitor line to the luer lock of the return
pressure port and press OVERRIDE. If the
fluid barrier is damaged, change the set
(press STOP, then CHANGE SET.)
Return pressure sensor failed. End treatment via STOPb. Call service.
Calcium syringe will be empty in To install a full syringe when this advisory
5 minutes. appears, press CHANGE SYR/LINE and
follow instructions on the screen.
Then return to alarm screen and press
CONTINUE.
The calcium syringe is not loaded. Press the CHANGE SYR/LINE softkey
to load a calcium syringe. Then press
RETEST to restart Syringe Test. If failure
recurs, end treatment via DISCONNECT.
Call service.
The calcium syringe is not Check the function of the syringe pump
loaded although the “Citrate with in Diagnose Screen – Syringe Pump
integrated calcium” method has on page 6:36. Perform a calibration,
been selected. see Calibration Screen – Syringe Pump
Calibration on page 6:66.
If malfunction, replace the syringe pump.
Check Access
Observation:
When running with an operating point below –10 mmHg, this alarm occurs if access
pressure is 50 mmHg or 70 mmHg (if blood flow>200 ml/min) above or below its
operating point, or if the pressure rises above 0 mmHg.
When running with an operating point in the range between –10 mmHg and +20
mmHg, this alarm occurs if the access pressure is 50 mmHg or 70 mmHg (if blood
flow>200 ml/min) below its operating point, or if the access pressure is 10 mmHg or
more above its operating point.
When running with an operating point above +20 mmHg, this alarm occurs if the
access pressure drops below +10 mmHg.
Blood flow rate is too high. Decrease blood flow rate, return to alarm
screen and press CONTINUEa.
Check Return
Observation:
This alarm occurs if return pressure is 50 mmHg or 70 mmHg (if blood
flow>200ml/min) above its operating point.
NOTE: An operating point is the pressure value when the pressure is considered
stable after an event (alarm, change of blood flow, etc).
Blood flow rate is too high. Decrease blood flow rate, return to alarm
screen and press CONTINUE. This alarm
self-clears once condition no longer exists.
Observation:
Alarm occurs when pressure exerted by syringe pump indicates syringe line may be
clamped. All pumps are stopped while confirmation of clamping is in progress.
This alarm self-clears when condition no longer exists.
Note: If this alarm is not cleared within 8 seconds the Advisory: Syringe Line
Clamped alarm occurs.
Download Interrupted
Observation:
Download of history data to the technical data card has failed.
The technical data card is full. Insert an empty technical data card into
the technical data card holder. Press
DOWNLD DATA to retry downloading the
history data.
There is no technical data card in Insert a new technical data card into
the technical data card holder or the the technical data card holder. Press
technical data card in the holder is DOWNLD DATA to retry downloading the
damaged. history data.
Internal malfunction related to the Press CONTINUE to clear the alarm and
technical data card holder/reader. proceed without downloading history
data. If alarm recurs during subsequent
treatments, call service.
Internal malfunction related to the Check the function of the PCMCIA board
technical data card holder/reader. in Diagnose Screen – Communication on
page 6:45. If malfunction, replace the
board.
Filter is Clotting
Observation:
Increasing TMP and/or Pressure Drop.
Note: TMP value in the MARSFLUX filter is not considered for this alarm during
CRRT MARS therapy.
Ultrafiltration is too high. Lower TMP by: (a) decreasing the PBP,
replacement and/or patient fluid removal
rates; (b) increasing the blood flow rate.
Press OVERRIDEc; continue to monitor
the set.
Air leak between deaeration If the fluid barrier is not wet with blood,
chamber monitor line and return secure monitor line to the luer lock of the
pressure sensor. return pressure port and press OVERRIDE.
If the fluid barrier is wet with blood, press
STOP and change the set.
Syringe pump may have failed. Check the function of the syringe pump
in Diagnose Screen – Syringe Pump
on page 6:36. Perform a calibration,
see Calibration Screen – Syringe Pump
Calibration on page 6:66.
If malfunction, replace the syringe pump.
HP Cartridge is Clotting
Observation:
Increasing Pressure Drop.
Inadequate anticoagulation of the Press STOP, change the set or test patient’s
extra corporeal circuit. clotting parameters and adjust if needed.
Air leak between deaeration If the fluid barrier is not wet with blood,
chamber monitor line and return secure monitor line to the luer lock of the
pressure sensor. return pressure port and press OVERRIDE.
If the fluid barrier is wet with blood, press
STOP and change the set.
Syringe pump may have failed. Check the function of the syringe pump
in Diagnose Screen – Syringe Pump
on page 6:36. Perform a calibration,
see Calibration Screen – Syringe Pump
Calibration on page 6:66.
If malfunction, replace the syringe pump.
Incomplete Bolus
Observation:
Appears when a bolus is interrupted. The blood pump has been stopped, either by
the operator or another alarm.
Observation:
Main power is lost and system operates on battery backup.
MARS Treatment
CRRT MARS treatment ongoing Set the MARS pump to the prescribed
for more than 1 minute. flow rate and press the START softkey on
the MARS monitor. Press CONTINUE on
the Prismaflex screen to return to Status
screen. Make sure that all blue clamps are
open.
Memory Back-Up
Observation:
Applicable when machine configuration does not include the back-up battery (check
with the local representative for more information).
Alarm recurs due to old battery or Leave the machine on or operate for more
broken internal wiring. than 24 hours.
If the alarm does not self-clear within 24
hours, call service.
Observation:
Increasing Pressure Drop.
Inadequate anticoagulation of the Press STOP, change the set or test patient’s
extra corporeal circuit. clotting parameters and adjust if needed.
Note: The Warning: Plasmafilter clotted alarm occurs when the blood in the
Plasmafilter is clotted.
Blood flow rate is too high or Decrease blood flow rate or decrease PBP
plasmafiltration rate is too high. and/or replacement flow ratesc.
Air leak between deaeration If the fluid barrier is not wet with blood,
chamber monitor line and return secure monitor line to the luer lock of the
pressure sensor. return pressure port and press OVERRIDE.
If the fluid barrier is wet with blood, press
STOP and change the set.
Filter or return pressure sensor Clear the alarm to reach Status screen.
failed. Press SYSTEM TOOLS and perform
SELF-TEST. If the pod problem is not
solved, press STOP and end the treatment.
Turn off machine. Call for service.
Syringe pump may have failed. Check the function of the syringe pump
in Diagnose Screen – Syringe Pump
on page 6:36. Perform a calibration,
see Calibration Screen – Syringe Pump
Calibration on page 6:66.
Self-Test Overdue
Observation:
Periodic self-test failed completion within the last 150 minutes of treatment.
Syringe will be empty in 5 min. To install a full syringe when this advisory
appears, press CHANGE SYRINGE and
follow instructions on screen. Then return
to alarm screen and press CONTINUE.
Syringe line on the disposable set Inspect syringe line; remove any clamps;
is clamped, kinked or obstructed in kinks, or other obstructions. Press
another way. CONTINUE.
The syringe pump failed. Check the function of the syringe pump
in Diagnose Screen – Syringe Pump
on page 6:36. Perform a calibration,
see Calibration Screen – Syringe Pump
Calibration on page 6:66.
If malfunction, replace the syringe pump.
Observation:
Hours of use have reached the operator-set “Time to Change Set” limit for this
therapy/set combination.
A “Time to Change Set” advisory Press STOPe and change the set or press
limit has been reached. OVERRIDE and continue to monitor the
setf.
Warning:
The Prismaflex disposable set must be changed after 72 hours of use. Continued use
beyond this limit could result in rupture of the pump segments.
Note: To ensure adequate filter performance, it is recommended that CRRT
disposable sets are changed every 24 hours of use.
During CRRT MARS treatment: Press STOPe and change the disposable
A “Time to Change Set” advisory sets on both the Prismaflex control
limit has been reached. unit and the MARS monitor or press
OVERRIDE and continue to monitor the
setf.
Note: Do not use the X-MARS kit beyond 24 hours. The adsorption columns
(diaMARS IE 250 and diaMARS AC 250) are likely to be saturated after this
operating time.
Observation:
Access transmembrane pressure has reached user-set pressure limit.
Inadequate anticoagulation of the Press STOP, change the set or test patient’s
extra corporeal circuit. clotting parameters and adjust if needed.
Note: The Warning: Plasmafilter clotted alarm occurs when the blood in the
Plasmafilter is clotted.
Filter or effluent pressure sensor Clear the alarm to reach Status screen.
failed. Press SYSTEM TOOLS and perform
SELF-TEST. If the pod problem is not
solved, press STOP and end the treatment.
Turn off machine. Call for service.
Or operator's action directs wrong
measurement.
Syringe pump may have failed. Check the function of the syringe pump
in Diagnose Screen – Syringe Pump
on page 6:36. Perform a calibration,
see Calibration Screen – Syringe Pump
Calibration on page 6:66.
If malfunction, replace the syringe pump.
Observation:
Transmembrane pressure has reached user-set pressure limit.
Air leak between deaeration If the fluid barrier is not wet with blood,
chamber monitor line and return secure monitor line to the luer lock of the
pressure sensor. return pressure port and press OVERRIDE.
If the fluid barrier is wet with blood, press
STOP and change the set.
Filter or effluent pod failure. Clear the alarm to reach Status screen.
Press SYSTEM TOOLS and perform
SELF-TEST. If the pod problem is not
solved, press STOP and change the set.
Filter or effluent pressure sensor Clear the alarm to reach Status screen.
failed. Press SYSTEM TOOLS and perform
SELF-TEST. If the pressure problem is not
solved, press STOP and end the treatment.
Turn off machine. Call for service.
Syringe pump may have failed. Check the function of the syringe pump
in Diagnose Screen – Syringe Pump
on page 6:36. Perform a calibration,
see Calibration Screen – Syringe Pump
Calibration on page 6:66.
If malfunction, replace the syringe pump.
Footnotes
a. CONTINUE clears the alarm and resets all operating points except for the return
pressure operating point if it is above +10 mmHg.
b. Pressing STOP stops all pumps, clears the alarm, and displays the Stop screen.
The following options are available: resume treatment, change set, end treatment, or
temporarily disconnect patient and recirculate sterile saline though set.
c. Alarm can also be overridden if operator decides action is not necessary at this
time. Alarm self-clears when condition no longer exists.
d. Too many unsuccessful attempts to clear this alarm could lead to error in patient
fluid balance/fluid removal that could result in patient injury or death. If alarm
reoccurs, press HISTORY and verify fluid removal accuracy. In case of discrepancy
between the prescribed value and fluid removed, consult physician and discontinue
the treatment if required.
e. Pressing STOP stops all pumps and displays the Stop screen. The set can be
changed by pressing CHANGE SET on the Stop screen. Alarm clears when set is
unloaded.
f. Alarm can also be overridden if operator decides action is not necessary at this
time. Alarm clears when set is unloaded.
g. CONTINUE clears the alarm and resets all operating points.
Air Detector
Air bubble detector failed self-tests. Press RETEST. If alarm does not clear,
end treatment via DISCONNECT or
manuallya. Call service. Do not use device
until serviced.
Return line not installed or Install return line in air bubble detector.
improperly installed in air bubble When ready, press CONTINUE.
detector.
Air bubble detector failed self-tests. Check the functions of the air bubble
detector in Diagnose Screen – Air Detector
on page 6:34. Perform a calibration, see
Calibration Screen – Air Detector on page
6:85 If malfunction, replace the Air bubble
detector.
Observation:
Effluent line not properly installed in blood leak detector. Blood leak detector failed
self-tests.
Effluent line is not installed, is Press line into detector from bottom
improperly installed, or is removed up; route through tubing guides. Press
from detector. RETEST.
Blood leak detector failed. If alarm does not clear, change set via
CHANGE SET or end treatment via
DISCONNECTa. Call service.
Blood leak detector failed. Check the function of the Blood leak
detector in Diagnose Screen – BLD (Blood
Leak Detector) on page 6:43.
If malfunction, replace the Blood leak
detector.
Blood Pump
Observation:
Rate of Blood pump is incorrect.
Thumb screw in center of rotor has Check the screw, remedy if needed.
loosened.
Observation:
This alarm appears during priming only.
The calcium syringe is not loaded. Press the CHANGE SYR/LINE to load a
calcium syringe. Then press RETEST to
restart the Syringe Test. If failure recurs,
end treatment via DISCONNECT. Call
service.
The syringe pump failed. Check the function of the syringe pump
in Diagnose Screen – Syringe Pump
on page 6:36. Perform a calibration,
see Calibration Screen – Syringe Pump
Calibration on page 6:66.
If malfunction, replace the syringe pump.
Checksum Interrupted
External force on return line clamp. Check return line clamp. Press RETEST.
Return line clamp failed. If alarm does not clear, change set via
CHANGE SET or end treatment via
DISCONNECTa. Call service.
Return line clamp failed. Check the function of the return line clamp
in Diagnose Screen – Clamp and Pinch
Valves on page 6:41.
If malfunction, replace the Return line
clamp.
Observation:
Error Code: 2 to 7
Due to:
Code=2 No communication with the protective task
Code=3 Communication link error on the protective slave
Code=4 Communication link error on the control system
Code=5 Missing status command from protective slave
Code=6 Missing alarm command from protective slave
Code=7 The protective task isn’t able to send message to the slave
See “Due to” message on alarm Turn machine off, remove return line from
screen. return line clamp, and return blood (when
applicable).
Note: Treatment can not resume using the
loaded set once blood has been returned.
Restart machine. Once Query screen
appears, make choice and carefully follow
instructions.
If alarm recurs, end treatment manually
(see above). Call service and report failure
code before using machine again.
Dialysate Pump
Observation:
Rate of dialysate (green) pump is incorrect.
Thumb screw in center of rotor has Check the screw. Remedy if needed.
loosened.
Observation:
This alarm appears during priming only.
The bar tray of the dialysate scale Place the scale in open position and then
has not been pulled out and then in closed position. Press RETEST. If this
pushed into the control unit to does not clear the alarm, end treatment via
attach the dialysate bag. DISCONNECT. Call service.
The scale position sensor failed. End treatment via DISCONNECT. Call
service.
Effluent Pump
Observation:
Rate of effluent (yellow) pump is incorrect.
Thumb screw in center of rotor has Check the screw. Remedy if needed.
loosened.
Observation:
This alarm appears during priming only.
The bar tray of the effluent scale Place the scale in open position and then
has not been pulled out and then in closed position. Press RETEST. If this
pushed into the control unit to does not clear the alarm, End treatment via
attach the effluent bag. DISCONNECT. Call service.
The scale position sensor failed. End treatment via DISCONNECT. Call
service.
Observation:
Error Code: 1 to 6
Turning Fluid pumps or Blood Turn machine off, remove return line from
pump when machine in Safe state; return line clamp, and return blood (when
Clamp forced to wrong position applicable).
when machine in Safe state; No Note: Treatment can not resume using the
communication. loaded set once blood has been returned.
Restart machine. Once Query screen
appears, make choice and carefully follow
instructions.
If alarm recurs, end treatment manually
(see above). Call service and report failure
code before using machine again.
Library Data
Return line installed in air bubble Remove line from air bubble detector,
detector before loading a set. then close door of air bubble detector.
Press RETEST. If alarm doesn’t clear, turn
machine off. Call service.
Tubing detection switch failed. Check the function of the Tubing detection
switch, see Diagnose Screen – Air
Detector on page 6:34.
If malfunction, replace the Air detector.
Return line installed in Return Line Remove line from Return Line Clamp.
Clamp before loading a set. Press RETEST. If alarm doesn’t clear, turn
machine off. Call service.
Tubing detection switch failed. Check the function of the Tubing detection
switch in Diagnose Screen – Clamp and
Pinch Valves on page 6:41.
If malfunction, replace the Return clamp.
The lower pinch valve is in the Remove any obstructions and press
wrong position for the therapy RETEST. If this does not clear the alarm,
selected and the current infusion end treatment via DISCONNECT. Call
method selected (Pre/Post) due to service.
obstructions.
The lower pinch valve failed. End treatment via DISCONNECT. Call
service.
The lower pinch valve failed. Check the function of the lower pinch
valve in Diagnose Screen – Clamp and
Pinch Valves on page 6:41.
If malfunction, change the lower pinch
valve.
Memory Error
Observation:
Error Code: number 1, 3 – 7
Due to:
Code=1 Memory error on Protective task.
See “Due to” message on alarm Turn machine off, remove return line from
screen. return line clamp, and return blood (when
applicable).
Note: Treatment can not resume using the
loaded set once blood has been returned.
Restart machine. Once Query screen
appears, make choice and carefully follow
instructions.
If alarm recurs, end treatment manually
(see above). Call service and report failure
code before using machine again.
Return line not installed or not Open door of air bubble detector and insert
properly installed in air bubble line into air bubble detector. If return
detector. line is installed in the air bubble detector,
press line into detector from bottom up
and route securely through tubing guides.
Press RETEST. If alarm doesn’t clear, end
treatment via DISCONNECT. Call service.
Tubing detection switch failed. Check the function of the Tubing detection
switch, see Diagnose Screen – Air
Detector on page 6:34.
If malfunction, replace the Air detector.
No Line in Clamp
Return line not installed or not Insert line into the clamp. Press RETEST.
properly installed in Return Line If alarm doesn’t clear, end treatment via
Clamp. DISCONNECT. Call service.
Tubing detection switch failed. Check the function of the Tubing detection
switch in Diagnose Screen – Clamp and
Pinch Valves on page 6:41.
If malfunction, replace the Return clamp.
Normalization Failed
Observation:
Attempt to normalize blood leak detector has failed.
Filter blood leak; defective effluent Press CHANGE SET and follow the
line; air bubble in effluent line instructions to load a new set. If alarm
at level of BLD; effluent line not recurs with new set, detector has failed.
correctly installed; blood leak Press DISCONNECT to end treatment.
detector failed. Call service.
Note: The Malfunction:
Normalization failed alarm is
displayed when the blood leak
detector normalization has failed 3
times in a row.
Blood leak detector failed. Check the function of the Blood leak
detector in Diagnose Screen – BLD (Blood
Leak Detector) on page 6:43.
If malfunction, replace the Blood leak
detector.
PBP Pump
Observation:
Rate of pre-blood (white) pump is incorrect.
Thumb screw in center of rotor has Check the screw. Remedy if needed.
loosened.
Observation:
This alarm appears during priming only.
The bar tray of the PBP scale has Place the scale in open position and then
not been pulled out and then pushed in closed position. Press RETEST. If this
in the control unit to attach the PBP does not clear the alarm, end treatment via
bag. DISCONNECT. Call service.
The scale position sensor failed. End treatment via DISCONNECT. Call
service.
Hardware failure on pressures Turn machine off, remove return line from
circuit board. return line clamp, and return blood (when
applicable). Call service.
Observation:
Zero test of one or more pressure sensors failed.
One or more pressure sensors failed If alarm does not clear, turn off machine.
or are incorrectly calibrated. Call service.
One or more pressure sensors failed Check the function of the pressure
or are incorrectly calibrated. sensors in Diagnose Screen – Pressure
Pod Reposition on page 6:30. Perform
a calibration, see Calibration Screen –
Pressure Sensors Calibration on page 6:64.
If malfunction, change the pressure
sensors.
Prime Self-Test
Observation:
Code: 1 to 28.
One or more of the tests conducted Softkeys on alarm screen vary, depending
during prime self-test failed. upon failure reason. All softkeys clear the
alarm.
DISCONNECT provides instructions to
unload/remove set.
NEW SET gives instructions to unload set,
load a new set, and start a new priming
cycle.
REPRIME provides instructions to reprime
the set.
RETEST restarts the prime test.
Observation:
Code: 1–7.
Due to: Pressure pod/sensor. All affected pods are reported.
Code=1 Access
Code=2 Filter
Code=3 Access and Filter
Code=4 Effluent (CRRT, TPE)
Code=5 Access and Effluent (CRRT, TPE)
Code=6 Filter and Effluent (CRRT, TPE)
Code=7 Access, Effluent and Filter (CRRT, TPE)
Possible cause(s): Operator action(s):
Pressure pod(s) not installed; debris Install/check that all reported pressure
in sensor housing(s); leaking pod. pod(s) on the alarm screen are installed
correctly. Press RETEST.
Observation:
Code=16
Due to: Return pressure sensor.
Chamber monitor line not securely Verify the fluid barrier is not wet/
connected to return pressure port. damaged. If not wet/damaged, secure
monitor line to the luer lock of the return
pressure port and press REPRIME to prime
the same set again. If the fluid barrier is
wet/damaged, press DISCONNECT and
use CHANGE SET to load/prime a new set.
Air in set and bad priming quality. Press REPRIME to prime the set again.
Observation:
Code=17 and 18
Due to: Blood leak detector normalization timeout or Blood leak detector threshold
error.
Effluent line not correctly installed Reinstall effluent line (from bottom
in blood leak detector. up); route through tubing guides. Press
RETEST.
Air bubble in effluent line at level Dislodge bubble by removing line from
of blood leak detector. detector / tapping on tube. Press RETEST.
Set not fully primed. Check for clamped lines and for
connections; remedy. Press REPRIME and
follow instructions. If failure recurs after
the above Operator Responses, retry with
a new set (Press NEW SET and follow
instructions.)
Blood leak detector failed. If failure occurs with the new set, unload
set via DISCONNECT. Call service and
report failure code.
Blood leak detector failed. Check the function of the Blood leak
detector in Diagnose Screen – BLD (Blood
Leak Detector) on page 6:43.
If malfunction, replace the Blood leak
detector.
Observation:
Code=19
Due to: Air/pumps security test.
Presence of air at ABD level. Disconnect monitor line and refill the
chamber.
Prime Self-Test
Observation:
Code=20
Due to: Pump occlusivity test.
Return line not properly installed Press REPRIME. Install return line in the
in return line clamp; obstruction in released return line clamp and prime the
return line clamp. same set again.
If failure occurs again, press
DISCONNECT and use CHANGE SET to
load/prime a new set.
Deaeration chamber monitor line Verify the fluid barrier is not damaged and
not connected to return pressure tighten fluid barrier connection to chamber
port; errors occurred during monitor line. If not damaged, secure
priming cycle. monitor line to the luer lock of the return
pressure port and press REPRIME to prime
again the same set. If the fluid barrier is
Pump(s) failed, return pressure Check the function of the Return, Effluent
sensor failure or leak in pressure and Filter pressure sensors in Diagnose
ARPS circuit. Screen – Pressure Pod Reposition on
page 6:30. Check the pressure sensors
and pressure ARPS circuit for leakage. If
leakage is detected, remedy the pressure
pod sealing cones, the pressure sensor,
pressure valves, ARPS pump alt ARPS
circuit.
Perform a “Verification of slave pump
rotor” test, see point 5 in Component
Replacement on page 6:17.
Check the function of the Blood pump
in Diagnose Screen – Pumps Diagnose
on page 6:26. If malfunction, replace the
Blood pump.
Check the function of the Return line
clamp in Diagnose Screen – Clamp and
Pinch Valves on page 6:41.
If malfunction, replace.
Prime Self-Test
Observation:
Code=21 – 23
Due to: Pinch valve(s).
Pinch valve(s) segment(s) not Press RETEST. If failure recurs, retry with
properly positioned in pinch a new set (Press NEW SET and follow
valve(s). instructions.)
Prime Self-Test
Observation:
Code=24
Due to: 24 volt / 12 volt.
24 volt / 12 volt test failed. Check that the ARPS circuit are connected
to each of the pressure sensor valve. Check
the function of the ARPS in according to
point 10, 11 in Diagnose Screen – Pressure
Pod Reposition on page 6:30.
If malfunction, replace ARPS pressure
sensor alt ARPS pump.
Prime Self-Test
Observation:
Code=25
Due to: Return clamp sensor.
Obstruction in return line clamp. Press and hold return clamp button. With
the other hand, remove obstruction. Press
RETEST.
Return clamp sensor failed. Check the function of the Return line
sensor in Diagnose Screen – Clamp and
Pinch Valves on page 6:41.
If malfunction, replace the Return clamp
sensor.
Prime Self-Test
Observation:
Code=26
Due to: 24 volt Return clamp sensor.
24 volt and return clamp sensor Press RETEST. If failure recurs, unload
tests failed. set via DISCONNECT. Call service and
report failure code.
24 volt and return clamp sensor Check that the ARPS circuit are connected
tests failed. to each of the pressure sensor valve. Check
the function of the ARPS in according
to point 10, 11 in Diagnose Screen –
Pressure Pod Reposition on page 6:30.
If malfunction, replace ARPS pressure
sensor alt ARPS pump. Check the function
of the Return line sensor in Diagnose
Screen – Clamp and Pinch Valves on page
6:41.
If malfunction, replace the Return clamp
sensor.
Observation:
Code=27
Due to: TMPa.
Filter or effluent pressure pod not Install/check that all reported pressure
installed; debris in filter and/or pod(s) on the alarm screen are installed
effluent sensor housings. correctly. Press RETEST.
Filter, effluent, or return pressure If alarm occurs with a new set, press
sensor failed; ARPS failed. unload set via DISCONNECT. Call service
and report failure code.
Filter, effluent, or return pressure Check the function of the ARPS according
sensor failed; ARPS failed. to point 10, 11 in Diagnose Screen –
Pressure Pod Reposition on page 6:30.
Check the function of the pressure sensors
in Diagnose Screen – Pressure Pod
Reposition on page 6:30.
If deviation, perform a calibration, see
Calibration Screen – Pressure Sensors
Calibration on page 6:64.
If malfunction, replace the ARPS and/or
pressure sensors.
Observation:
Code=28
Due to: Syringe Pump HW.
Replacement Pump
Observation:
Rate of replacement (purple) pump is incorrect.
Thumb screw in center of rotor has Check the screw. Remedy if needed.
loosened.
Observation:
Rate of replacement 2 (green) pump is incorrect.
Thumb screw in center of rotor has Check the screw. Remedy if needed.
loosened.
Observation:
This alarm appears during priming only.
The bar tray of the replacement Place the scale in open position and then
scale has not been pulled out and in closed position. Press RETEST. If this
then pushed into the control unit to does not clear the alarm, end treatment via
attach the replacement bag. DISCONNECT. Call service.
The scale position sensor failed. End treatment via DISCONNECT. Call
service.
Scales
Observation:
Scale in question is specified on the alarm screen.
Specified scale is out of calibration. Press RETEST. If alarm does not clear,
end treatment via DISCONNECTd. Turn
machine off, remove return line from
return line clamp, and return blood (when
applicable). Call service.
Specified scale is out of calibration. Calibrate the scale, see Calibration Screen
– Scales Calibration on page 6:61. Verify
the function of the scale in Diagnose
Screen – Scale Diagnose on page 6:28.
If deviation, replace the scale.
Hardware failure on scales circuit Check the function of the scale in Diagnose
board. Screen – Scale Diagnose on page 6:28.
If malfunction, replace the scale.
Observation:
Zero test of one or more scales failed.
Unexpected presence of bag. Remove bag from scale. Close scale and
press RETEST.
Carrying bar missing from one or Place carrying bar back on scale. Close
more scales. scale and press RETEST.
Foreign objects are touching scales Make sure nothing is touching scales and
or hanging from scale carrying no foreign objects are on scale carrying
bars. bars. Press RETEST.
One or more scales failed. If alarm does not clear, turn off machine.
Call service.
Observation:
For Possible cause(s) and Operators action(s),
see correspondent code for Prime Self-Test Alarm.
Code=1–7, Pressure pod/sensor
Code=16, Return pressure sensor
Code=18, Blood leak detector threshold error
Code=24, 24 volt / 12 volt
Code=25, Return clamp sensor
Code=26, 24 volt Return clamp sensor
WARNING
The blood leak detector must be re-normalized if the effluent line
is removed and then reinserted into the blood leak detector after
treatment (Run mode) has started.
WARNING
The syringe pump failed. Check the function of the syringe pump
in Diagnose Screen – Syringe Pump
on page 6:36. Perform a calibration,
see Calibration Screen – Syringe Pump
Calibration on page 6:66.
If malfunction, replace the syringe pump.
Observation:
Code: 1–9.
Code = 1 Working mode incongruence between Syringe pump and set mode.
Code = 2 Rate is incorrect.
Code = 3 Syringe pump is moving in the wrong direction.
Code = 4 Configuration incongruence between Syringe pump and the system / wrong
version of firmware.
Code = 5 Lower sensor out of order.
Code = 6 Maximum of load sensor / unable to read force (short circuit).
Code = 7 Minimum of load sensor / unable to read force (grounded).
Code = 8 Working mode incongruence between Syringe pump and Control unit.
Code = 9 Encoder signal error / engine mechanically blocked.
Note: Always call service to repair the syringe pump and clear the alarm.
The upper pinch valve is in the Remove any obstructions and press
wrong position for the therapy RETEST. If this does not clear the alarm,
selected due to obstructions. end treatment via DISCONNECT. Call
service.
Upper pinch valve failed. Check the function of the lower pinch
valve in Diagnose Screen – Clamp and
Pinch Valves on page 6:41.
If malfunction, change the lower pinch
valve.
Internal malfunction related to Turn machine off, remove return line from
the machine Power Supply or the return line clamp, and return blood (when
Power supply cabling. applicable). Call service.
Footnotes
a. Manual termination instructions are provided at the end of the Troubleshooting
chapter in the Operator’s manual for Prismaflex.
b. This alarm must be cleared in Service mode by an authorized service technician.
c. Memory Error code 6 is triggered when Flow Rate Discrepancy occurs. A Flow
Rate Discrepancy is when any flow rate displayed on the Status screen differs from
that displayed on the Enter Flow Settings Screen.
d. DISCONNECT key is available only if set is loaded onto control unit.
e. OVERRIDE briefly overrides the alarm. Monitor closely.
Display Error
Observation:
Display goes blank, status lights go off, non-mutable buzzer sounds.
Power loss, internal power supply Turn off machine to stop buzzer, end
failure. treatment manually, if desireda.
Display Error
Observation:
Display goes blank momentarily, then screen reappears.
Display Error
Observation:
Display goes blank or logo screen fails to leave display, status lights may still be
on, no buzzer.
Internal power supply failure; Turn machine off, remove return line from
internal malfunction. return line clamp, and return blood (when
applicable). Call service.
Internal power supply failure; Check the voltage on the boards. Check
internal malfunction. function of the PC 104 board. Check the
connections between the PC 104 board
and the display.
Observation:
Display “floats around”
Loader
Observation:
Loader is already in loaded position, so that a set cannot be loaded.
Observation:
Effluent bag is tinged pink or red.
Effluent contains red blood cells, Send effluent sample to laboratory for
but level is below blood leak analysis. If red blood cells are present,
detection limit. change the set via STOPb.
Hemolysis is occurring due to Verify that the correct clamps are open for
occlusion. the therapy in use, especially for the access
line (red) and return line (blue). Verify
there are no kinks in the access and return
lines. If hemolysis continues, change the
set via the STOP keyb.
Set Connections
Observation:
Leakage from set connections.
Observation:
Softkeys won’t work.
Footnotes
a. Manual termination instructions are provided in the operator’s manual.
b. See “Change Set and End Treatment Procedures” in “End Mode” in the operator’s
manual.
Note: Line power is required to start the Prismaflex control unit, even
if equipped with a back-up battery.
General
To ensure proper operation, a qualified service technician shall perform
an Electrical Safety Inspection (ESI) of the Prismaflex control unit
at regular intervals. ESI should be performed at every maintenance
service (Base-service), but also after replacement of some components
in the Prismaflex control unit according to section “Component
replacement with needed ESI” on page 6:12. Additionally if the
equipment has been exposed to unexpected electrical events on the
main supply or unintentional ingress of fluid has occurred, a full
Electrical Safety Inspection shall be performed. The information
needed to perform ESI is provided in this instruction.
• Visual inspection
The purpose of the PET test is to verify that the protective earthed parts
of the control unit are properly connected to protective earth, providing
a safe low electrical potential on these in case of insulation failure.
When performing the ESI, which requires access to the interior of the
control unit, you must have proper electrostatic safety devices (i.e.
wrist grounding straps or grounding mats) in place to prevent damage
to electrostatic sensitive components within the control unit.
Note:
• If the Prismaflex control unit is tested according to IEC 60601-1
(IEC 60601-1: Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance), this
complies with requirements in IEC 62353 (IEC 62353: Medical
electrical equipment – Recurrent test and test after repair of
medical electrical equipment).
Visual inspection
The visual inspection is an important part of the elctrical safety
inspections of the Prismaflex control unit.
1. Exterior parts including covers: look for major damage, cracks etc.
Test equipment
Safety tester according to IEC 62353.
Test
1. Check that the resistance between the protective earth connection
of the mains plug and the earth connector at the bottom plate where
the scales are attached is ≤ 300 mΩ.
Test
1. Start the Prismaflex control unit, let it pass initialization test and
be in Setup mode.
ELT / PLT
Test equipment
A safety tester set to measure according to IEC 60601–1.
2. Measure the supply voltage with the safety tester and register the
value in Record of ESI - Machine identification - Supply voltage -
Measured.
Note:
To avoid damages on the safety tester, follow the user manual for the
safety tester.
3. Measure the earth leakage current, Single Fault Condition, with the
safety tester by running Earth Leakage Current test. Test also with
reversed polarity of supply voltage.
4. Check that the highest measured readings don’t exceed the limit
values in following table:
Test
1. Start the Prismaflex control unit, let it pass initialization test and
be in Setup mode.
4. Check that the highest measured readings don’t exceed the limit
values in following table:
Visual inspection
Remarks:
Description Approved
Measured value
check
Check that the resistance between the Applied part:
conductivity clip and the connector for
potential equalization is according to
section Check of Conductivity Clip, in
this chapter. __________ ⃞
(Limit value type BF applied part: 1.1
MΩ ± 0.2 MΩ)
(Limit value type CF applied part: 3.24
MΩ ± 0.15 MΩ) ____________ MΩ
Check Approved
Description Measured value
no check
Check that the resistance between
the protective earth connection
of the mains plug and the earth
1 ⃞
connector at the bottom plate
where the scales are attached is
≤ 300 mΩ. _________mΩ
Check that the resistance between
the protective earth connection
2 of the mains plug and the earth ⃞
connector at the PCB holder at the
door is ≤ 300 mΩ. __________mΩ
Check that the resistance between
the protective earth connection
3 of the mains plug and the earth ⃞
connector at the ARPS pump is
≤ 300 mΩ. __________mΩ
Check that the resistance between
the protective earth connection
4 of the mains plug and the ⃞
earth connector for potential
equalization is ≤ 300 mΩ. __________mΩ
Description Approved
Measured value
check
File the highest measured earth leakage
current, normal condition reading
according to section ELT-Earth Leakage
⃞
Current Test, in this chapter:
(Limit value 230 VAC: max 500 μA)
(Limit value 115 VAC: max 250 μA) __________ μA
File the highest measured earth leakage,
single fault condition reading according
to section ELT-Earth Leakage Current
⃞
Test, in this chapter:
(Limit value 230 VAC: max 1000 μA)
(Limit value 115 VAC: max 500 μA) __________ μA
Description Approved
Measured value
check
File the highest measured patient
leakage current, normal condition
reading according to section
PLT-Patient Leakage Current Test, in __________ μA DC
this chapter: ⃞
(Limit value CF, 115 or 230 VAC: max
10 μA DC, max 10 μA AC)
(Limit value BF, 115 or 230 VAC: max
10 μA DC, max 100 μA AC) __________ μA AC
File the highest measured patient
leakage current, single fault
condition reading according to
section PLT-Patient leakage Current __________ μA DC
Test, in this chapter: ⃞
(Limit value CF, 115 or 230 VAC: max
50 μA DC, max 50 μA AC
(Limit value BF, 115 or 230 VAC: max
50 μA DC, max 500 μA AC) __________μA AC
Compare with the measured leakage currents at the last ESI1 and make
a judgment if the changes are approved or not for the next operational
period of the machine. Write notes here:
____________________ ____________________
Name of testing service engineer Signature
____________________ ____________________
1If this is the ESI at installation please make comparison with the "Production
Summary" measured values supplied by the manufacturer at delivery of the
Prismaflex control unit.
• Power Supply
• Main Switch
• Display
• Pinch Valves
• Venous Clamp
• Loader Motor
• Blood Pump
• Scale Plate
• ARPS Pump
• Syringe Pump
CAUTION
Make sure to have proper electrostatic safety device
(i.e. wrist grounding straps or grounding mats) in place to prevent
damage to electrostatic sensitive components inside the
Prismaflex control unit.
CAUTION
Tools Needed
• Torx T-20
• Torx T-15
• 8 mm Hex
• PC (Personal Computer)
• Stopwatch
Working Time
• Replacement: 30 minutes
Prismaflex® PM Kit
• Blood pump dampers, 2 pcs
• PM procedure, 1 pce
• PM checklist, 1 pce
3. Clean any dust, debris, and/or dried fluids from the external and
internal Prismaflex control unit surfaces, including the fan outlet,
rear panel inlet, bottom plate (covering the scales) and pump rotors.
Note: Clean spills from the surface of the Prismaflex control unit using
a mild detergent (Never use detergents with germicides).
4. The tubing path through the blood leak detector should be cleaned
as required to remove liquid or other debris. Using a flossing
action, clean inside the detector with a lint-free cloth and 70%
isopropyl alcohol. Dry thoroughly when finished.
7. Inspect the Prismaflex control unit for the following and replace
as necessary:
CAUTION
Do not use sodium hypochlorite (Bleach®) to clean the pump crank.
Use of sodium hypochlorite (Bleach®) on this component may
damage it.
To clean the touch screen use the following disinfectants: Isopropyl
alcohol (70°) Sodium hypochlorite solution (active chlorine from
50,000 to 60,000 ppm)/Bleach diluted with water at a ratio of 1:50.
CAUTION
Blood leakage from the pressure pod diaphragm (Access and Filter)
1. Clean the external surface involved using a towel dipped in a
disinfectant solution.
1.1. Make sure that the Prismaflex control unit is switched off.
1.3. Loosen the Torx screw (T-20) holding the plate where the
PIB board is mounted.
1.4. Swing out the bracket where the PIB board is mounted to
access the PC board.
1.5. Push the mental retaining tab outward and remove the
battery from its socket.
1.6. Insert the new battery onto the board (ensure that the +
polarity side of the battery faces outward).
2.1. Remove the sealing cone from each transducer port (access,
filter, effluent and 5th).
2.3. Install new sealing cones so that they are sealed around the
tip of the transducers, with the enlarged part of the transducer
port protruding through the seal. Never use lubricant!
4.1. Use a flat blade screw driver to remove the Slave pump
Rotor.
4.2. Compress the rotor by hand and use a pair of long nose
pliers to remove the old dampers.
4.3. Compress the rotor and push the new dampers over the
screw head with your fingers.
Note: Do not adjust the screws.
4.5. Continue from step 1 until all rotors has been updated.
5.2. Erase the content of the card and put it back into the
Prismaflex control unit.
6.1. Loosen the four Torx screws (T-20) on the back of the ARPS
pump housing and remove the pump assembly.
6.2. Separate the two halves of the pump and remove the old
pump segment.
6.3. Remove the tubing connector from the pump segment. Save
the tubing connector for use on the new pump segment.
Dispose the filter and pump segment.
6.5. Ensure that the female slot of the ARPS pump assembly
lines up properly with the male slot on the ARPS motor
collar. Secure the pump housing assembly to the ARPS
bracket with the four screws.
Note: Start the four screws by hand. Make sure the threads on the
screws grip properly before applying any force on to the screw.
6.7. Verify that the ARPS tubes between the pressure pods are
not kinked, dry, or too short. If this is the case, replace the
tubing.
• Scales
• Air detector
• Syringe Pump
• BLD
• Internal
• Communication
• Clean screen
• SW configuration
• Diagnose Screens
• Calibration Screens
Enter the service screens by pressing the time, displayed on the upper
right corner of the touch screen. This can only be done at the initial
start up screen.
CAUTION
Only an authorized service technician should access the Service
mode.
CAUTION
Note: For blood pump the TACH and the Encoder value should be
the same as the SET speed (±10%).
The screen displays the averaged scale readings for the control and
protective Weight Transducers, and the associated A/D values. The
weight and A/D values at each Weight Transducer are continuously
displayed in the row below the scale name.
Control A/D: A/D value read by the channel used for the control side
Protective A/D value read by the channel used for the protective
A/D: side
Ref1 A/D and voltage references connected to 2 A/D channel
Ref2 A/D:
Control weight in grams read by the control side with the actual
grams: calibration parameters
Protective weight in grams read by the protective side with the
grams: actual calibration parameters
Switch: is the indication about the status of the switch (scale
open / scale close)
2. Verify that the values on the screen are within the accepted values
defined in “Accepted values for scale verification” below.
3. Place the calibration weight (part A+B) on the scale and monitor
the values. Verify that the values on the screen are within the
accepted values defined in “Accepted values for scale verification”.
4. Place the calibration weight (part A+B, part C+D) on the scale
handle and monitor the values.
5. Verify that the values on the screen are within the accepted values
seen above in “Accepted values for scale verification”.
6. Gently press down the scale by hand until the Protective Grams
and Control Grams on the screen shows approximately 9000g.
8. Verify that the values on the screen are within the accepted values
defined in “Accepted values for scale verification”.
9. Gently lift the scale by hand until the Protective Grams and Control
Grams on the screen shows approximately 5000g.
11. Verify that the values on the screen are within the accepted values
defined in “Accepted values for scale verification”.
The screen displays the averaged pressure readings in mmHg and the
associated A/D values. It also shows the status of the five valves.
11. Press the DIRECTION softkey until the Motor Direction row
displays Decrease, then press the MOTOR softkey to begin
changing the pressure.
The screen displays the different lights and alarm sounds that are
present in the Prismaflex control unit.
This screen is used for verifying the functionality of the ABD (Air
Bubble Detector).
Force Applied: is the actual force applied to the syringe plunger clamp calculated by the
actual calibration coefficients
ADC value: is the AD value read by the syringe pump
End of Stroke: Normal = no end of stroke Eos
Eos Up = end of stroke up (not working for all types of clip holders) Eos
Eos Down = end of stroke down
Overload: this field indicates when a overload condition is reached. The overload
threshold is a value syringe dependent
Syringe state: indicates if the syringe is loaded or not loaded
Syringe indicates the actual condition of the syringe pump and can assume the
Functioning: following values:
Not present. – if the syringe is not installed in its holder
Loading. – if the syringe pump is loading the syringe
Wai. Hepar. – if the syringe pump is waiting for automatic
heparinisation
Adaptation – when the heparinisation starts Normal, in working
condition
Protective mm/s read by the Protective side. In the new software version the unit
rate: is mm/s
Manual mode indicates if the mode is disabled or enabled reading the status of the syringe
and Automatic pump
mode:
Counter: this is the number of encoder pulses measured during movement in the
upwards direction, when the syringe pump is in Manual mode
5. Press the up key to load the syringe properly and close the syringe
latch. The message Syringe state: Loaded should
appear.
3. Press the ADJUST RATE softkey. Use the UP/DOWN ARROW soft-
keys on the right side of the screen. Set the delivery rate for the
syringe pump to 0,018 mm/s. The rate can be set between 0 and
0.5 mm/s.
3. Press the ADJUST RATE softkey. Use the UP/DOWN ARROW soft-
keys on the right side of the screen. Set the delivery rate for the
syringe pump to 0,018 mm/s. The rate can be set between 0 and
0.5 mm/s.
6. When the delivery rate accuracy is verified, press the STOP softkey.
2. Enable the Automatic mode and press the BOLUS softkey and start
the stopwatch at the same time.
Prime verification
1. Perform Syringe State Verification above.
This screen is for verifying the functionality of the Clamp and the
Pinch Vales.
2. Make sure the clamp is open. Press the CONTROL POWER softkey.
The clamp should close and the Clamp status display
should also indicate a closed reading. The display related to the
CONTROL POWER softkey should indicate OFF.
3. To open the clamp, press the CONTROL POWER softkey until the
display reads ON.
5. To open the clamp, press the PROTECT POWER softkey until the
display related to the softkey reads ON.
Note: The Normalize value that appears after the NORMAL. softkey
is pressed is stored only for use during the current Service mode. The
Blood Leak Detector Normalize value is re-calibrated and stored
during the Prime Self-Test.
6. Fill the tubing segment with water and install it in the blood leak
detector housing.
This screen is for verifying the functionality of the Bar code reader
and Loader.
2. Press the UNLOAD softkey and verify that the pumps turn
clockwise and that the cartridge clamp loader moves in the
appropriate direction.
4. If the bar code reader is not able to read the label the
following text appears Bar code label: Er. Press the
BAR CODE CONFIG softkey: a different bar code reader
configuration is set. Retry to press the BAR CODE TEST softkey.
5. Press the UNLOAD softkey and verify that the pumps turn
clockwise and the set is unloading.
4. Switch off the Prismaflex control unit and remove the technical
data card from its reader.
5. Read data stored on the technical data card and verify that a *.LOX
file is located in folder for current year. The *.LOX file shall have
a time stamp that corresponds to the time displayed on screen.
• M Month (Base36)
• D Day (Base36)
C = 12 (Year 2012)
6 = June
J = 19
7 = 7 (7 AM)
I = 18
Copied file comes from a Prismaflex control unit with serial number
2519 and time for the download was 7:18, 19th of June, 2012.
3. On the remote alarm device, verify that alarm light and/or buzzer
is activated.
This screen is used for setting the Last PM Date and the time interval
for PM advisory. See section “Preventive Maintenance” on page 6:13.
Calendar shows the interval time for the next occurrence of the Advisory "Preventive
Timer: Maintenance Due" and is setable in the range between 1 month and 5 years
with steps of 1 month
Operation This interval is setable in the range between 500 hour and 6000 hour
Timer:
Last PM shows the date of the last service intervention
Date:
3. Press the SAVE PM DATE softkey to save the current date. The
date is stored as the Last PM Date.
Bar code
The bar code contains information about the setup and configuration of
the machine, such as hardware/software configuration and calibration
parameters.
• first point 0 g
WARNING
The used calibration weight must correspond to the weight set in
the Service – Scales screen ( Part A + Part B = 5200 g
and Part C + Part D = 1800 g).
Failure to use the corresponding weight at the second and third
calibration point can cause serious injury or death to the patient.
WARNING
3. Wait for the scale to stabilized for the first calibration point, 0 g.
Press CONFIRM when the message Scale STABLE appears.
6. Let the 5200 g weight hang on middle hook and place the 1800
g weight on one of the selected scales outer hooks. (If another
reference point than 7000 g is chosen, place the weight on
the selected scale and enter the weight of reference using the
UP/DOWN ARROW softkeys.)
Note: If the values read from the scale at the first cali-
bration point are outside the valid intervals, the message
Scale out of tolerance, cannot be calibrated ap-
pears on the screen. In this case the scale is damaged, and needs to
be replaced.
If the values read from the scale at the second or third calibration point
are outside the valid intervals, check that the correct weight is used.
Then make sure that the correct weight value is entered and press the
RETRY softkey.
Verify the Scale
8. Gently press down the scale (approx. + 2 kg) by hand and then
release the scale again.
10. Gently lift up the scale (approx. – 2 kg) by hand and then release
the scale again.
11. Wait for the Scale STABLE message, press CONFIRM softkey.
WARNING
If calibration fails repeatedly, replace the pressure sensor.
WARNING
11. If the test fails, repeat the above for all the pressure sensors one at
a time.
WARNING
The used calibration weight must correspond to the weight set in
the Service – Syringe Pump screen (Part A + Part B +
Part C + Part D = 7000 g).
Failure to use the corresponding weight at the second calibration
point can cause serious injury or death to the patient.
WARNING
2. Move the plunger clamp to the same level as the tubing guide
for the Effluent and PBP line, use the up/down arrow hard keys,
located above the syringe pump.
4. With the ADC value stable, press the CONFIRM FIRST softkey.
Reset offset
1. Remove any weight from the Syringe plunger.
The ADC value represents the value read by the syringe pump (AD
Converter) when a weight is applied. The ADC value is displayed
on the screen.
If the value read from the pump at the second calibration point is
outside the valid interval, most probably a wrong calibration weight is
used, and both the message;
Calibration failed. Check weight on plunger
and retry appears on the screen, and a new softkey RETRY becomes
available. Before pressing the RETRY softkey, check that the correct
3. The DISPLAY ORDER softkey changes the way the current date is
displayed: day/month/ year or month/day/year
Set the volume and alarm tone to one of the following values: LOW,
MODERATE or HIGH.
Default values
• ID = 10
• RS232 = NO (disabled)
CAUTION
This Service mode section must be restricted to medical authorized
personal. Critical parameters to be customized will be calculated by
the Prismaflex system and are relevant to the patient safety. Check
with physicians for proper setting of parameters.
CAUTION
CITRATE
3. When the CITRATE softkey is pressed, the softkeys
SOLUTION 1, 2, 3 are activated.
CALCIUM
14. When the CALCIUM softkey is pressed, the softkeys
SOLUTION 1, 2, 3 are activated.
19. The softkeys SOLUTION ID, and CALCIUM CONC. are activated
and it is possible to edit the solution.
2. Use the soft key numbers to enter the serial number found at the
label at the back of the machine. Some Control units have letters
before the serial number on the type label and they are not entered.
Note: The entry for serial number is deleted (set to zero) during a
software update.
Tools needed: Prismaflex disposable set return line tube filled with
fluid.
Graduated Length
Measure and enter the length between graduation marks that correspond
to the Syringe Size (e.g. the distance between 0 ml and 50 ml if
the size of the syringe is 50 ml). Use UP/DOWN ARROW softkeys
to set the value.
2. Press the CONFIRM ALL softkey to confirm the settings and return
to the Service – Calibrate screen.
WARNING
A patient must not be connected to the Prismaflex System during
the functional checkout. Be sure that the checkout is conducted
using a container of water to substitute for the patient.
If a Malfunction alarm occurs during the functional checkout, the
Prismaflex control unit has failed the checkout. Do not use the
Prismaflex System until the problem has been corrected and the
Prismaflex System has passed the checkout.
WARNING
Supplies needed:
6. When the prime and the prime test are completed, press
CONTINUE. The Enter Treatment Settings screen
appears. Set the Loss/Gain Limit to 140 ml/3h. Press
CONFIRM ALL.
11. Note the hour and minute on the Status screen when the
Prismaflex control unit enters Run mode (this information can be
found in History screen, pressing Events softkey).
12. Let the Prismaflex control unit run for at least 15 minutes.
13. Place a clamp on the access line (red) below the cartridge.
The Warning: Access Pressure Extremely
Negative alarm should occur. Verify that the red light is flashing
and the audible alarm sounds with a high sound, 10 sound pulses
repeated approx. every 8 seconds.
14. Unclamp the access line and press the CONTINUE softkey on
the Warning screen. Verify that the alarm is cleared (Warning
screen leaves display, green light is lit).
16. Press the OVERRIDE softkey. The Advisory screen leaves the
display, but remains in Examine Alarms. Yellow light is lit, the
Prismaflex control unit returns to the Status screen and the battery
icon, in the top right corner of the display, is lit.
18. Press the STOP softkey, then press the END TREATMENT softkey
and follow the instructions to unload the set.
Schematics
Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Flow Rates and Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Blood Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
Automatic Blood Return Volume . . . . . . . . . . . . . . . . . . . . . . . 8:3
Replacement Solution/Fluid Flow Rate . . . . . . . . . . . . . . . . . . . 8:3
Dialysate Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:3
PBP Solution Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4
Patient Fluid Removal Performance / Patient Plasma Loss
Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4
Effluent Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:4
Syringe Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:5
Systemic, Prismaflex syringe pump anticoagulation method . . . 8:5
Citrate – Calcium, Prismaflex Syringe Pump anticoagulation
method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
TPE Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Pressure sensor range, accuracy and alarm limits . . . . . . . . . . . . . . 8:6
Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:6
Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7
Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:7
Effluent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9
Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9
Air Bubble Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9
Blood Leak Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:9
Alarm signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Audible . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Sound pressure levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Visual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:10
Physical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Weight, dimensions, etc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Scales Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Scale Weight Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Scale accuracy: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Line power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:11
Battery backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:12
External communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:12
Environmental data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13
Transportation and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13
Noise level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:13
Vibration levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14
Fluid spillage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14
Cleanability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:14
Electromagnetic Emissions and Immunity . . . . . . . . . . . . . . . . . . . 8:14
Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
AC Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
Defibrillation-proof Applied Part . . . . . . . . . . . . . . . . . . . . . . . . . . 8:19
CVVH; CVVHDF
Range 0 to 8000 ml/h
Increment 20 to 50 ml/h
CVVH
Predilution percentage 0 to 100%
Increment 5%
CVVHDF
Predilution percentage 0 (postdilution) or 100% (predilution)
TPE
Range 0 to 5000 ml/h
Increment 10 ml/h
Accuracy ± 30 ml/h
CVVHD; CVVHDF
Range 0 to 8000 ml/h
Increment 50 ml/h
Accuracy ± 30 ml/h
CRRT
Range 0 to 4000 ml/h
TPE; HP
Range 0 to 1000 ml/h
Note: Total PBP Volume is 2000
ml/treatment for TPE and HP.
Increment 30 ml/h < Qpbp < 100 ml/h: 2 ml/h
100 ml/h < Qpbp < 200 ml/h: 5 ml/h
200 ml/h < Qpbp < 1500 ml/h: 10 ml/h
Qpbp > 1500 ml/h: 50 ml/h
Qpbp = PBP Solution Flow Rate
Accuracy ± 30 ml/h
CRRT
Range 0 to 2000 ml/h
Increment 5 to 10 ml/h
TPE
Range 0 to 1000 ml/h
Increment 10 ml/h
Accuracy ±30 ml/h
±70 ml/3 hr
±300 ml/24 hr
Scales calibrated at ambient temperature
at which they will be used. Ambient
temperature change less than ±3 °C (5.4
°F) during treatment.
TPE Settings
Patient Hematocrit
Range 10 to 60%
Increment 1%
Default 30%
Range 0 to 10,000 ml
Increment 100 ml
Default 3000 ml
Range 0 to 5,000 ml
Increment 10 ml
Access
Return
Filter
Effluent
Patient safety
Audible
Characteristics
Can be silenced for 2 minutes, after which audible resumes if alarm
condition has not been remedied.
Unable to silence
Visual
Red flashing Warning and Malfunction alarms
Yellow flashing Caution alarms
Yellow constantly lit Advisory alarms
Scales Characteristics
Weight range for each scale includes the scale components (bar tray,
carrying bars).
Dialysate: 0 to 11 Kg
Replacement: 0 to 11 Kg
PBP: 0 to 11 Kg
Effluent: 0 to 11 Kg
Scale accuracy:
≤7 g error for a mass from 0 to 5200 g and,
≤14 g error for a mass from 5201 g to 11000 g.
Power
Line power
External communication
Remote Alarm Max voltage: 24 VAC
Max Current: 1 A
AMP CPC (Circular Plastic Connector),
4 pin, female connector
RS232 DB9–type, female connector
Ethernet 10base-T compatible
8 pin RJ45 female connector
Technical data card PCMCIA compatible memory card
Operation
Ambient Operating 16 °C to 38 °C
Temperature: (60 °F to 100 °F)
Ambient Operating 15% to 65% (Non-condensing)
Humidity (for control
units with serial number up
to PA5409):
Ambient Operating Lower ambient operating humidity
Humidity (for control limit:
units with serial number 15% (Non-condensing) in the temperature
from PA5410 and on): interval 16 °C to 38 °C.
Upper ambient operating humidity
limit:
85% (Non-condensing) in the temperature
interval 16 °C to 28 °C. In the temperature
interval 28 ºC to 38 ºC the upper limit
is reduced by 2% per degree and at
maximum ambient temperature (38 ºC)
the maximum operating relative humidity
is consequently 65% (Non-condensing).
Ambient Operating Air 70 to 106 kPa
Pressure: (525 to 795 mmHg)
Noise level
Noise level < 65 dB(A) over a 24 h period,
measured at a distance of 0.5 m from
the Prismaflex control unit, during
normal operation and without any alarm
condition.
Fluid spillage
Fluid Spillage: IPX1 (Protection against vertically falling
water drops)
As specified in IEC 60529
Cleanability
Cleanability: Not damaged by mild detergent; liquid
soap; ethyl alcohol (90%); isopropyl
alcohol (70%); sodium hypochlorite
(0.1%). Pump rotors are removable.
symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
1 Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
asses the electromagnetic environment due to fixed transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in
which the Prismaflex system is used exceeds the applicable RF compliance level
above, the Prismaflex system should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Prismaflex system.
2 Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3
V/m.
AC Leakage Current
Protective ground open
300 μA maximum rms 100/115 VAC, 50/60 Hz
500 μA maximum rms 220/240 VAC, 50/60 Hz
Electromagnetic Compatibility
Meets IEC 60601-1-2
Continuous Operation
The Prismaflex system is intended for continuous operation.
4 Defined by dividing priming volume and bag volume for user defined cartridge
in Custom mode.
5 Only for the line set. Blood volume for user defined cartridge shall be added for
total blood volume.
Equations
Blood pump flow rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
Filter pressure drop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
Effluent flow rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:2
Transmembrane pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3
Total predilution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3
CRRT prescription indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:3
Filtration Fraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:4
Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:4
Patient fluid removed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:5
Access transmembrane pressure . . . . . . . . . . . . . . . . . . . . . . . . . . 9:5
Software Calculations of Target Patient Plasma Loss . . . . . . . . . . . 9:5
Formulas used in TPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6
Patient plasma loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:6
PBP flow rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:7
Syringe flow rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9:7
QBP = Qb + Qpbp
Where ΔPfil is Filter pressure drop (mmHg), Pfil is Filter pod pressure
(mmHg) and Pret is Return sensor pressure (mmHg)
Where Qeff is Effluent rate (ml/h), Qpfr is Patient fluid removal rate
(ml/h), Qpbp is PBP flow rate (ml/h), Qrep is Replacement solution
rate (ml/h), Qdial is Dialysate solution rate (ml/h) and Qsyr is Syringe
flow rate (ml/h)
Where Qeff is Effluent rate (ml/h), Qppl is Patient plasma loss rate
(ml/h) and Qrep is Replacement fluid rate (ml/h)
Total predilution
The Prismaflex software calculates the total predilution value, which
is the ratio of prefilter blood dilution to the total blood dilution. Total
predilution is calculated according to the formula below:
Where PRE%tot is Total predilution (%), Qpbp is PBP flow rate (ml/h),
Qreppre is Pre-filter replacement flow rate (ml/h), Qrep is Replacement
flow rate (ml/h)
With
Filtration Fraction
Doses
DCRRT-eff = Qeff / BW
Where Vpfr is Patient fluid removed (ml), Veff is Effluent bag volume
(ml), Vpbp is PBP pumped (ml), Vdial is Dialysate pumped (ml), Vrep
is Replacement solution pumped (ml) and Vsyr is Syringe solution
pumped (ml).
T = Vrep(tot) / Qrep
Vppl(tgt) = Qppl × T
where FF is Filter fraction (%), Qppl is Patient plasma loss rate (ml/h),
Qrep is Replacement flow rate (ml/h), Qb is Operator set blood flow
rate (ml/h), Hct is Hematocrit (%), Qpbp is PBP flow rate (ml/h) and
Qplasma is plasma flow rate (ml/h)
Veff(tgt) = Qeff × T
where Veff(tgt) is Target effluent (ml), Qeff is Effluent rate (ml/h) and T
is Treatment time (h)
Vppl(tgt) = Qppl × T
where Vppl(tgt) is Target patient plasma loss (ml), Qppl is Patient plasma
loss rate (ml/h) and T is Treatment time (h)
Where Qpbp is PBP flow rate (ml/h), Qb is Blood flow rate (ml/h), Dcit
is Citrate dose expressed in millimole per liter of blood (mmol/l blood)
and [Cit] is citrate concentration of the PBP solution (mmol/l).